K091013 - SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (FDA 510(k) Clearance)

K091013 is an FDA 510(k) clearance for the SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on July 30, 2009 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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