CLA-2-90:OT:RR:NC:N4:405
Daniel Hong
Allergan
2525 Dupont Drive
Irvine, CA 92612
RE: The tariff classification of breast implant sizers from Costa Rica.
Dear Mr. Hong:
In your letter dated March 27, 2012, you requested a tariff classification ruling. No samples were provided.
You state the imports will be:
A. NATRELLE Silicone – Filled Breast Implant Sizers
B. NATRELLE Re – Sterilizable Breast Implant Sizers
C. NATRELLE Saline – Filled Breast Implant Sizers
Per the brochures you attached:
“The NATRELLE Silicone filled breast implant sizers are designed to provide a volumetric tool to assist with final implant size and shape selection. Filled with lightly pigmented silicone gel to avoid confusion with the actual breast implant, the NATRELLE silicone sizer has a white patch which is permanently marked with the sizer volume.
NATRELLE Re – sterilizable Round Silicone Breast Implant Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of a breast implant to use.
The Allergan Saline Sizer is constructed of restricted grade medical silicone elastomer. The device consists of a shell and silicone tubing used for filling the sizer. The Allergen Sizer is supplied with an integral fill tube with a Luer adapter, and a tubing clamp to facilitate filling.”
For each, it is stated that they are not intended to be an implantable device.
Each type of sizer is designed to be inserted and removed in several sizes after the surgeon has made the incision, but before the final decision has been made as to which size breast implant will be inserted permanently. Breast implants in multiple sizes will be available to the surgeon in the Operating Room.
You propose classification in HTSUS 9021.39.00 as “other” Artificial parts of the body and parts or accessories thereof.
However, unlike all the examples in the Harmonized System Explanatory Note (HS EN) III to 9021, each size is inserted inside the patient for only a few minutes, at most, while the incision remains open and does not perform any function other than in the decision process regarding the size of the permanent breast implant. Although it is “associated with the broader activity of” artificial breast implantation, that is not sufficient to make it a part or accessory of the breast implant, noting the principle in CAFC 01-1049.
Somewhat analogously, trial cases of lenses used by ophthalmologists are classified in HTSUS 9018, per its HS EN I-C-3, even though eyeglasses themselves are not.
The applicable subheading for these three types of breast implant sizers will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" instruments and apparatus used in medical, surgical, or veterinary sciences, and parts and accessories thereof. The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at (646) 733-3012.
Sincerely,
Thomas Russo
Director
National Commodity Specialist Division