K041316 - ANTIMICROBIAL ALGINATE DRESSING (FDA 510(k) Clearance)

K041316 is an FDA 510(k) clearance for the ANTIMICROBIAL ALGINATE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions, Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on August 5, 2004 after a review of 80 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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