K063173 - MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (FDA 510(k) Clearance)

K063173 is an FDA 510(k) clearance for the MODIFICATION TO SILVER ALGINATE II WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on November 3, 2006 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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