2ND SKIN NON-STICK MOIST BURN PADS (K894898) - FDA 510(k) Clearance

K894898 is an FDA 510(k) clearance for the 2ND SKIN NON-STICK MOIST BURN PADS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on August 23, 1989 after a review of 22 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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