POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) (K121522) - FDA 510(k) Clearance

K121522 is an FDA 510(k) clearance for the POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polyremedy, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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