- To : Automated Broker Interface
Subject: FDA PRODUCT CODE CHANGES: RADIATION EMITTING PRODUCTS
TO: ALL ABI FILERS
FROM: THE FOOD & DRUG ADMINISTRATION
SUBJECT: PRODUCT CODE CHANGES: RADIATION EMITTING PRODUCTS
THE FOOD & DRUG ADMINISTRATION HAS REVAMPED ITS PRODUCT CODES
FOR RADIATION EMITTING PRODUCTS. AS A RESULT 190 NEW CODES HAVE
BEEN ADDED AND 25 OBSOLETE CODES WILL BE END DATED.
THESE CODES ARE AVAILABLE FOR USE IMMEDIATELY.
THE NEW CODES ALREADY APPEAR IN THE FDA WEB BASED PRODUCT CODE
BUILDER APPLICATION, HOWEVER THE TUTORIAL STILL
LISTS THE OBSOLETE CODES AND SHOULD BE UPDATED SHORTLY.
THE NEW CODES ARE:
INDUSTRY 94 IONIZING NON-MEDICAL DEVICES AND COMPONENTS
94R--AU NIGHT VISION SCOPE, HIGH VOLTAGE VACUUUM TUBES
94R--AV HIGH VOLTAGE TUBES, HIGH VOLTAGE VACUUM TUBES
94R--AW CATHODE RAY TUBES (WITHOUT ELECTRONICS CHASSIS)
94R--AX HIGH VOLTAGE VACUUM SWITCHES
94R--AY OSCILLOSCOPE (EXEMPTED), TV RECEIVERS & PRODUCTS
94R--AZ TELEVISION RECEIVER, MEDICAL IMAGING, COLOR
94R--BA TELEVISION RECEIVER, MEDICAL IMAGING MONOCHROME
94R--BB TELEVISION RECEIVER, GENERAL PURPOSE, COLOR
94R--BC TELEVISION RECEIVER, GENERAL PURPOSE, MONOCHROME
94R--BD VIDEO MONITOR, MEDICAL IMAGING, COLOR
94R--BE VIDEO MONITOR, GENERAL PURPOSE, COLOR
94R--BF VIDEO MONITOR, MEDICAL IMAGING, MONOCHROME
94R--BG VIDEO MONITOR, GENERAL PURPOSE, MONOCHROME
94R--BH PROJECTOR, TV RECEIVERS & PRODUCTS
94R--BI TV VIEW FINDER, TV RECEIVERS & PRODUCTS
94R--BJ COLD-CATHODE GAS DISCHARGE TUBES
94R--BK BETATRON, NON-MEDICAL ACCELERATORS
94R--BL CYCLOTRON, NON-MEDICAL ACCELERATORS
94R--BM MICROTRON, NON-MEDICAL ACCELERATORS
94R--BN SYNCHROTRON, NON-MEDICAL ACCELERATORS
94R--BO STERILIZERS, NON-MEDICAL ACCELERATORS
94R--BP INDUSTRIAL ACCELERATOR, NON-MEDICAL
94R--BQ SECURITY ACCELERATOR, NON-MEDICAL
94R--BR DIAGNOSTIC X-RAY EQUIPMENT (NONCERTIFIED)
94R--BS INDUSTRIAL X-RAY SYSTEMS (EXCLUDING CABINET)
94R--BT BOTTLE FILL CHECKER, INDUSTRIAL X-RAY SYSTEMS (EXCLUDING
CABINET)
94R--BU THICKNESS GAUGE, INDUSTRIAL X-RAY SYSTEMS (EXCLUDING
CABINET)
94R--BV SECURITY X-RAY, INDUSTRIAL X-RAY SYSTEMS (EXCLUDING
CABINET)
94R--BW DIFFRACTION, NON-MEDICAL, ANALYTICAL X-RAY SYSTEMS
94R--BX SPECTROSCOPY, NON-MEDICAL, ANALYTICAL X-RAY SYSTEMS
94R--BY FLUORESCENCE, NON-MEDICAL, ANALYTICAL X-RAY SYSTEMS
94R--BZ X-RAY CONTROLS - COMBINATION, MEDICAL DIAGNOSTIC X-RAY
EQUIPMENT
94R--CA X-RAY CONTROLS - FLUOROSCOPIC, MEDICAL DIAGNOSTIC X-RAY
EQUIPMENT
94R--CB X-RAY CONTROLS - RADIOGRAPHIC, MEDICAL DIAGNOSTIC X-RAY
EQUIPMENT
94R--CC C-ARM FLUOROSCOPIC X-RAY SYSTEM, MEDICAL DIAGNOSTIC X-RAY
EQUIPMENT
94R--CD X-RAY IMAGE RECEPTOR, MEDICAL DIAGNOSTIC X-RAYEQUIPMENT
94R--CE CABINET X-RAY, INDUSTRIAL, NON-MEDICAL
94R--CF EXPLOSIVE DETECTION SYSTEMS, CABINET X-RAY SYSTEMS
NON-MEDICAL
94R--CG SECURITY X-RAY (INCLUDES BAGGAGE X-RAY), CABINET X-RAY
SYSTEMS, NON-MEDICAL
94R--CH CARGO X-RAY, CABINET X-RAY SYSTEMS, NON-MEDICAL
94R--CI CEPHALOMETRIC DEVICES, DENTAL DIAGNOSTIC X-RAY EQUIPMENT
94R--CJ VETERINARY IMAGING, VETERINARY X-RAY SYSTEMS
94R--CK VETERINARY DIAGNOSTIC X-RAY THERAPY, VETERINARY X-RAY
SYSTEMS
94R--CL ION BEAM IMPLANTER, INDUSTRIAL PARTICLE BEAM SYSTEMS
94R--CM MICROSCOPE (ELECTRON BEAM), NON-MEDICAL INDUSTRIAL
PARTICLE BEAM SYSTEMS
94R--CN BACKSCATTER X-RAY SYSTEMS, PERSONNEL SECURITY SYSTEMS
94R--CO TRANSMISSION X-RAY SYSTEM, PERSONNEL SECURITY SYSTEMS
94R--CP MOBILE SYSTEMS, CARGO NON-INTRUSIVE SECURITY SYSTEMS
94R--CQ STATIONARY SYSTEMS, CARGO NON-INTRUSIVE SECURITY SYSTEMS
INDUSTRY 95 LIGHT EMITTING NON-DEVICE PRODUCTS
95R--DV AUTOMOTIVE ACCESSORY, AUTOMOBILE OR TRANSPORT VEHICLE,
LASER
95R--DW GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
95R--DX MERCURY VAPOR LAMP
95R--DY METAL HALIDE LAMP, MERCURY VAPOR LAMPS
95R--DZ LOW-POWER LASER LIGHT SHOW PROJECTOR, DISPLAY PRODUCTS
95R--EA HIGH-POWER LASER LIGHT SHOW PROJECTOR (OUTPUT>5MW)
95R--EB HIGH-POWER LASER LIGHT SHOW, DISPLAY PRODUCTS
95R--EC LASER VIDEO PROJECTOR, DISPLAY PRODUCTS
95R--ED LASER ADVERTISING DISPLAY SYSTEM
95R--EE LASER VISUAL DISPLAY - DISPLAY RETINAL IMAGE, NON-MEDICAL
DISPLAY PRODUCT
95R--EF SUNTAN BED, SUNLAMP PRODUCTS (CERTIFIED), NON-MEDICAL
95R--EG SUNTAN LAMP, SUNLAMP PRODUCTS (CERTIFIED), NON-MEDICAL
95R--EH TABLETOP SUNLAMP SYSTEM (CERTIFIED), NON-MEDICAL
95R--EI LASER SCIENCE EDUCATION PRODUCTS
95R--EJ TOY, NOVELTY, PLAY LASER PRODUCT
95R--EK RESEARCH LASER, SCIENTIFIC, LABORATORY LASER PRODUCTS
95R--EL GUIDE-STAR LASER SYSTEM, RESEARCH SCIENTIFIC, LABORATORY
LASER PRODUCTS
95R--EM SPECTROSCOPY INSTRUMENT, LASER, RESEARCH SCIENTIFIC,
LABORATORY LASER PRODUCTS
95R--EN PARTICLE-SIZE MEASURING INSTRUMENT, RESEARCH, SCIENTIFIC,
LABORATORY LASER PRODUCTS
95R--EO ANALYTICAL MEASURING AND DETECTION, RESEARCH, SCIENTIFIC,
LABORATORY LASER PRODUCTS
95R--EP SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT
LASER PRODUCTS
95R--EQ RANGING (GEODIMETER) LASER PRODUCTS, SURVEYING, LEVELING,
ALIGNMENT LASER PRODUCTS
95R--ER ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT
LASER PRODUCTS
95R--ES LASER POINTER, SURVEYING, LEVELING, ALIGNMENT
LASER PRODUCTS
95R--ET LASER TARGET DESIGNATOR, SURVEYING, LEVELING, ALIGNMENT
LASER PRODUCTS
95R--EU LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING,
ALIGNMENT LASER PRODUCTS
95R--EV LASER AIMING PRODUCT, NON-VISBLE, SURVEYING, LEVELING,
ALIGNMENT LASER PRODUCTS
95R--EW IR LASER ILLUMINATOR WITH ALIGNMENT AID/NIGHT VISION
SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER
95R--EX IR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY,
SECURITY, SURVEILLANCE LASER
95R--EY COLLISION-AVOIDANCE LASER SYSTEM, SAFETY, SECURITY,
SURVEILLANCE LASER
95R--EZ LASER TRAFFIC SIGNAL, SAFETY, SECURITY, SURVEILLANCE LASER
95R--FA LASER AUTOMOTIVE LIGHTING & SIGNALS, SAFETY, SECURITY,
SURVEILLANCE LASER
95R--FB IR LASER INTRUSION DETECTION/SECURITY SYSTEM, SAFETY,
SECURITY, SURVEILLANCE LASER
95R--FC LASER RADAR (LIDAR) OR SPEED MEASUREMENT, SAFETY,
SECURITY, SURVEILLANCE LASER
95R--FD LASER WEAPON (MILITARY OR POLICE) SAFETY, SECURITY,
SURVEILLANCE LASER
95R--FE LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
95R--FF LASER WELDER, MATERIALS PROCESSING LASER PRODUCTS
95R--FG MICROELECTRONIC MASK OR CHIP CHECKING/REPAIR, MATERIAL
PROCESSING LASER PRODUCTS
95R--FH UV CURING, MATERIAL PROCESSING LASER PRODUCTS
95R--FI PRINT INDUSTRY PLATE MAKER, MATERIAL PROCESSING
LASER PRODUCTS
95R--FJ PROCESS CONTROL, MATERIAL PROCESSING LASER PRODUCTS
95R--FK LASER VISION, MATERIAL PROCESSING
95R--FL LASER MICROMETER, MATERIAL PROCESSING
95R--FM LASER-BASED MATERIAL POSITIONING SYSTEMS
95R--FN FIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
95R--FO IR FREE-SPACE DATA TRANSMIT/CONTROL, LASER
95R--FP REMOTE CONTROLLER, LASER, DATA MEASUREMENT, TRANSMIT
95R--FQ INTERFEROMETRIC POSITION MEASURING PRODUCTS, LASER
95R--FR PRODUCT INCORPORATING CERTIFIED CLASS 1 LASER
DATA MEASUREMENT, TRANSMIT, CONTROL
95R--FS REPROGRAPHICS, LASER UTILITY/PERIPHERAL LASER PRODUCT
95R--FT LASER PRINTER, UTILITY/PERIPHERAL LASER
95R--FU LASER FAX MACHINE, UTILITY/PERIPHERAL LASER PRODUCTS
95R--FV CD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL
LASER PRODUCTS
95R--FW DVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER
PRODUCTS
95R--FX CD-R, CD-RW RECORDER, LASER UTILITY/PERIPHERAL LASER
PRODUCTS
95R--FY DVD-R, DVD+R, DVD-RAM, DVD+RW, DVD-RW RECORDER,
UTILITY/PERIPHERAL LASER PRODUCTS
95R--FZ UPC READER (BAR CODE RECORDER), UTILITY/PERIPHERAL
LASER PRODUCTS
95R--GA PRODUCT INCORPORATING CERTIFIED CLASS 1 DATA
95R--GB VETERINARY LASER, IN VITRO AND OTHER MEDICAL LASER
PRODUCTS
95R--GC X-RAY FIELD INDICATOR LIGHT (LASER), POSITIONING MEDICAL
LASER PRODUCTS
95R--GD COUNTERFEIT DETECTION, ULTRAVIOLET SURVEILLANCE &
DETECTION PRODUCTS
95R--GE SCIENTIFIC CRYSTALLOGRAPHY, ULTRAVIOLET SURVEILLANCE &
DETECTION PRODUCTS
95R--GF FORENSICS, NONCOHERENT LIGHT SOURCE, ULTRAVIOLET
SURVEILLANCE & DETECTION PRODUCTS
95R--GG FORENSICS LASER, ULTRAVIOLET SURVEILLANCE & DETECTION
PRODUCTS
95R--GH TOILET SEAT SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS,
NON-MEDICAL
95R--GI HAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS,
NON-MEDICAL
95R--GJ COUNTERTOP SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS
95R--GK TOWEL CLEANER, ULTRAVIOLET HYGIENE PRODUCTS
95R--GM PHOTOCHEMICAL CURING AND ADHESIVE, ULTRAVIOLET
COMMERCIAL/CONSUMER PRODUCTS, NON-MEDICAL
95R--GN PHOTOCHEMICAL CURING AND ADHESIVE LASER, ULTRAVIOLET
COMMERCIAL/CONSUMER, NON-MEDICAL
95R--GO UV CURING, NONCOHERENT LIGHT SOURCE, ULTRAVIOLET
COMMERCIAL/CONSUMER
95R--GP BLACK LIGHT, ULTRAVIOLET COMMERCIAL/CONSUMER
95R--GQ COSMETOLOGY, ULTRAVIOLET COMMERCIAL/CONSUMER
95R--GR AIR PURIFIER, ULTRAVIOLET COMMERCIAL/CONSUMER
95R--GS WATER PURIFIER, ULTRAVIOLET COMMERCIAL/CONSUMER
95R--GT SPECTROSCOPY, ULTRAVIOLET FLUORESCENCE,
COMMERCIAL/CONSUMER
95R--GU X-RAY FIELD INDICATOR LIGHT (NON-LASER)
95R--GV VETERINARY OPTICAL, GENERAL OPTICAL MEDICAL PRODUCTS
95R--GW UV/IR RESEARCH PRODUCT, GENERAL OPTICAL, NON-MEDICAL
95R--GX FLUORESCENT LAMP, GENERAL OPTICAL, NON-MEDICAL
95R--GY IR INTRUSION DETECTOR, GENERAL OPTICAL, NON-MEDICAL
95R--GZ IR SECURITY, GENERAL OPTICAL PRODUCTS, NON-MEDICAL
95R--HA IR DATA TRANSMIT/CONTROL, GENERAL OPTICAL PRODUCTS,
NON-MEDICAL
95R--HB TUNGSTEN HALOGEN LAMP, GENERAL OPTICAL PRODUCTS
95R--HC HIGH PRESSURE MERCURY AND MERCURY XENON LAMP (SPECIFIC
PURPOSE ILLUMINATION), NON-MEDICAL
95R--HD IR REMOTE CONTROLLER, GENERAL OPTICAL PRODUCTS,
NON-MEDICAL
95R--HE AUTO FOCUS CAMERA, GENERAL OPTICAL PRODUCTS, NON-MEDICAL
95R--HF DIGITAL DISPLAY MONITOR, GENERAL OPTICAL PRODUCTS,
NON-MEDICAL
95R--HG LIGHT, SPECTRUM, BROAD (NON-MEDICAL), GENERAL OPTICAL
PRODUCTS, NON-MEDICAL
95R--HH LED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL
PRODUCTS, NON-MEDICAL
95R--ZN GENERAL INDUSTRIAL USE MATERIAL PROCESSING LASER PRODUCTS
95R--ZP HOME/OFFICE MACHINE INCORPORATING, UTILITY/PERIPHERAL
LASER
95R--ZS POSITIONING MEDICAL LASER PRODUCT
INDUSTRY 96 RADIO FREQUENCY EMITTING PRODUCTS
96R--CR MICROWAVE OVEN, CONSUMER (FOOD PREP)
96R--CS MICROWAVE OVEN, COMMERCIAL (FOOD PREP)
96R--CT TUNNEL/CONVEYOR, MICROWAVE OVENS (FOOD PREP)
96R--CU VENDING MACHINE, MICROWAVE OVENS (FOOD PREP)
96R--CV FOOD PROCESSING MICROWAVE HEATING AND DRYING PRODUCTS
96R--CW MATERIALS PROCESSING , MICROWAVE HEATING AND DRYING
PRODUCTS
96R--CX CLOTHES DRYER, MICROWAVE HEATING AND DRYING PRODUCTS
96R--CY MEDICAL WASTE/STERILIZER, MICROWAVE HEATING AND DRYING
PRODUCTS
96R--CZ MATERIALS PROCESSING, LABORATORIES, MICROWAVE HEATING
AND DRYING PRODUCTS
96R--DA DIELECTRIC HEATERS, INDUCTION HEATERS, RF SEALERS
96R--DB ELECTRIC BLANKET, HOUSEHOLD ELF PRODUCTS, NON-MEDICAL
96R--DC SHAVERS, HOUSEHOLD ELF PRODUCTS
96R--DD HAIR DRYER, HOUSEHOLD ELF PRODUCTS
96R--DE SEWING MACHINE, HOUSEHOLD ELF PRODUCTS
96R--DF MOTOR, HOUSEHOLD ELF PRODUCTS
96R--DG VETERINARY, MICROWAVE MEDICAL PRODUCTS
96R--DH AIR TRAFFIC CONTROL, MICROWAVE IDENIFICATION, SAFETY,
SECURITY, AND SURVEILLANCE PRODUCTS
96R--DI POLICE RADAR, MICROWAVE IDENTIFICATION, SAFETY, SECURITY,
AND SURVEILLANCE PRODUCTS
96R--DJ RF IDENTIFICATION, MICROWAVE IDENTIFICATION, SAFETY,
SECURITY, AND SURVEILLANCE PRODUCTS
96R--DK ELECTRONIC ARTICLE SURVEILLANCE (EAS), MICROWAVE I.D.,
SAFETY, SECURITY, AND SURVEILLANCE PRODUCTS
96R--DL STUN GUN, MICROWAVE IDENTIFICATION, SAFETY, SECURITY AND
SURVEILLANCE PRODUCTS
96R--DM ANTI-THEFT DETECTOR (NON-EAS), MICROWAVE IDENTIFICATION,
SAFETY, SECURITY, AND SURVEILLANCE PRODUCTS
96R--DN WALKIE-TALKIE, MICROWAVE COMMUNICATION, DATA TRANSMIT, AND
MEASUREMENT PRODUCTS
96R--DO MICROWAVE LAN, MICROWAVE COMMUNICATION, DATA TRANSMIT, AND
MEASUREMENT PRODUCTS
96R--DP WIRELESS (CORDLESS) TELEPHONE, MICROWAVE COMMUNICATION
DATA TRANSMIT, AND MEASUREMENT PRODUCTS
96R--DQ CB AMATEUR RADIO, MICROWAVE, COMMUNICATION, DATA TRANSMIT,
AND MEASUREMENT PRODUCTS
96R--DR REMOTE CONTROLLER, MICROWAVE , COMMUNICATION, DATA
TRANSMIT, AND MEASUREMENT PRODUCTS
96R--DS WEATHER DOPPLER, MICROWAVE, COMMUNICATION, DATA TRANSMIT,
AND MEASUREMENT PRODUCTS
96R--DT RF-EXCITED LIGHTING, MICROWAVE PRODUCTS
96R--DU PEST CONTROLLER, MICROWAVE PRODUCTS
INDUSTRY 97 SOUND EMITTING PRODUCTS
97R--AC NONDESTRUCTIVE TESTS, ULTRASONIC NON-MEDICAL DEVICES
97R--AD GAUGING, ULTRASONIC NON-MEDICAL DEVICES
97R--AE RANGING, ULTRASONIC NON-MEDICAL DEVICES
97R--AF CLEANER, ULTRASONIC NON-MEDICAL DEVICES
97R--AG WELDER, ULTRASONIC NON-MEDICAL DEVICES
97R--AH JEWELRY CLEANER, ULTRASONIC NON-MEDICAL DEVICES
97R--AI MOTION DETECTOR/OCCUPANCY ULTRASONIC NON-MEDICAL DEVICES
97R--AJ SECURITY SYSTEM, ULTRASONIC NON-MEDICAL DEVICES
97R--AK PEST REPELLER, ULTRASONIC NON-MEDICAL DEVICES
97R--AL MASSAGER, ULTRASONIC NON-MEDICAL DEVICES
97R--AM HUMIDIFIER, ULTRASONIC NON-MEDICAL DEVICES
97R--AN AUTO FOCUS CAMERA, ULTRASONIC NON-MEDICAL DEVICES
97R--AO INTRUSION ALARM/SECURITY, ULTRASONIC NON-MEDICAL DEVICES
97R--AP SCIENTIFIC USE ULTRASONIC PRODUCTS, NON-MEDICAL DEVICES
97R--AQ AUDIO SYSTEM/RADIO, SONIC NON-MEDICAL PRODUCTS
97R--AR TELEPHONE RINGER, SONIC NON-MEDICAL PRODUCTS
97R--AS VETERINARY DIAGNOSTIC ULTRASONIC PRODUCTS
97R--AT VETERINARY THERAPY ULTRASONIC PRODUCTS
THE FOLLOWING CODES ARE OBSOLETE AND WILL BE END DATED
APPROXIMATELY 30 DAYS AFTER THE FDA PROUCT CODE TUTORIAL IS
UPDATED. A SUBSEQUENT ADMIN MESSAGE WILL ISSUE REMINDING FILERS
WHEN THESE CODES ARE ABOUT TO BE END DATED.
94A--11 ACCELERATOR FOR NON-MEDICAL USE
94C--08 COLD-CATHODE GAS DISCHARGE TUBE FOR NON-MEDICAL USE
94H--04 HIGH VOLTAGE VACUUM TUBE
94H--06 HIGH VOLTAGE VACUUM SWITCH
94I--13 INDUSTRIAL X-RAY SYSTEM (EXCEPT CABINET)
94I--17 CABINET X-RAY SYSTEM
94N--14 ANALYTICAL X-RAY SYSTEM OR COMPONENT FOR NON-MEDICAL USE
94V--01 BOARDS, PRINTED CIRCUIT
94V--02 CIRCUIT BREAKER, AUTOMATIC
94V--05 CATHODE RAY TUBE
94V--07 TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION,
COMPUTER MONITOR
95L--22 LASER PRODUCT FOR NON-MEDICAL USE
95L--29 LASER LIGHT SHOW
95L--30 LASER PRINTERS
95L--31 CD PLAYERS (COMPACT DISC PLAYERS)
95L--32 CD PLAYER COMBINATION SYSTEMS
95U--19 SUNLAMP PRODUCT (PRE-STANDARD) FOR NON-MEDICAL USE
95U--20 ULTRAVIOLET PRODUCT (MISCELLANEOUS) FOR NON-MEDICAL USE
95U--28 MERCURY VAPOR LAMP FOR NON-MEDICAL USE
96H--02 MICROWAVE HEATING PRODUCT (EXCEPT OVEN FOR FOOD
PREPARATION) FOR NON-MEDICAL USE
96H--27 INDUSTRIAL DIELECTRIC HEATER
96M--01 MICROWAVE OVEN FOR FOOD PREPARATION
97U--09 ULTRASOUND PRODUCT FOR NON-MEDICAL USE
97Y--35 SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE
97Y--36 CORDLESS PHONES
THE FOOD & DRUG ADMINISTRATION