K090453 - SILVER ALGINATE 11 WOUND DRESSING (FDA 510(k) Clearance)

K090453 is an FDA 510(k) clearance for the SILVER ALGINATE 11 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 February 26, 2009 after a review of 3 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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