K112549 - IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (FDA 510(k) Clearance)

K112549 is an FDA 510(k) clearance for the IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AN.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalontechnologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on May 4, 2012 after a review of 246 days - an extended review 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: 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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