SILVERLON ADHESIVE STRIP

K984205 · Argentum International, LLC · FRO · Mar 19, 2007 · SU

Device Facts

• Record ID: K984205
• Device Name: SILVERLON ADHESIVE STRIP
• Applicant: Argentum International, LLC
• Product Code: FRO · SU
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Device Story

Silverlon™ Adhesive Strip is a wound dressing device. It is intended for use as a dressing for wounds. The device is applied topically to the wound site. It is not indicated for third-degree burns, nor is it labeled to accelerate wound healing or epithelization. It is not intended as a long-term, permanent, or no-change dressing, nor as an artificial skin. It is not labeled as a treatment or cure for any specific type of wound.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Wound dressing device. Specific materials, dimensions, and sterilization methods are not described in the provided text.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Mr. A. Bart Flick Research Director Argentum International LLC 36 Lake Rabun Road Lakemont, Georgia 30552

Re: K984205 Trade Name: Silverlon™ Adhesive Strip Regulatory Class: Unclassified Product Code: FRO Dated: November 24, 1998 Received: November 24, 1998

Dear Mr. Flick:

This letter corrects our substantially equivalent letter of February 22, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to device referents as a correst marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been the chaonielin accordance with the provisions of the Federal Food, Drug, and Cosmetic Act recrassified in accordine approval of a premarket approval (PMA). You may, therefore, (100) that as not required to the general controls provisions of the Act. The general market the devilos, but your to annual registration, for annual registration, listing of controlo pro researing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 - Mr. A. Bart Flick

4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 3 -- Mr. A. Bart Flick

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the prease contact to , "Misbranding by reference to premarket notification" (21CFR Part 102.97). You may obtain other general information on your responsibilities under the Act 007:57): Touring Sciall Careers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mardi X. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health