K133764 - CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL (FDA 510(k) Clearance)

K133764 is an FDA 510(k) clearance for the CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on March 13, 2014 after a review of 92 days - within the typical 510(k) review window.

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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