GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (K901369) - FDA 510(k) Clearance

K901369 is an FDA 510(k) clearance for the GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Sterling Drug, Inc. (New York, US). The FDA issued a Cleared decision on June 5, 1990 after a review of 74 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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