K103141 - LOW ADHERENT AFM AG DRESSINGS (FDA 510(k) Clearance)

K103141 is an FDA 510(k) clearance for the LOW ADHERENT AFM AG DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Milliken Healthcare Products, LLC (San Diego, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 88 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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