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NY R04062




June 6, 2006

CLA-2-30:RR:NC:2:238 R04062

CATEGORY: CLASSIFICATION

TARIFF NO.: 3005.90.5090

Ms. Melissa M. Traylor
FzioMed, Inc.
231 Bonetti Drive
San Luis Obispo, CA 93401

RE: The tariff classification of Oxiplex/SP® Gel

Dear Ms. Traylor:

In your letter dated May 31, 2006, you requested a tariff classification ruling.

The subject product, Oxiplex/SP® Gel, is an absorbable adhesion barrier

“Adhesions are abnormal connections between organs or tissues that form after trauma, including surgery. They consist of organized fibrin and fibrovascular scar tissue and complicate all areas of surgery.” Remington: The Science and Practice of Pharmacy, 20th Edition (p.1850)., in the form of a clear, synthetic, sterile gel. The gel is composed of polyethylene oxide and carboxymethylcellulose sodium stabilized with calcium chloride. Oxiplex/SP® Gel is intended to reduce post-surgical epidural adhesions “Post-surgical epidural adhesions can compress or tether the nerve root, often causing recurrent pain and radiculopathy following lumbar disc surgery.” See http://fziomed.com/news/newsreleases/newsrelease_12-12-05.html. in discectomy, laminectomy, and laminotomy procedures in spine surgery by acting as a temporary mechanical barrier separating opposing tissue surfaces. The gel is put up in a 3mL syringe that, together with a sterile, 5.42”, plastic applicator and instructions for use, is fitted into a sterile, thermoform (plastic) tray. The tray, in turn, is put up packaged for retail sale in a printed box.

The applicable subheading for the subject product will be 3005.90.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Other: Other: Other.” 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 merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at: www.fda.gov.

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 Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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