K061227 - HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER (FDA 510(k) Clearance)

K061227 is an FDA 510(k) clearance for the HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by The Hymed Group Corp. (Bethlehem, US). The FDA issued a Cleared decision on December 20, 2006 after a review of 232 days - an extended review 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. Standard predicate reliance. 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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