K871770 - AMERICAN PHARMASEAL WOUND DRESSING (FDA 510(k) Clearance)

K871770 is an FDA 510(k) clearance for the AMERICAN PHARMASEAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on June 26, 1987 after a review of 51 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.

View all American Pharmaseal Div. Ahsc devices