K884397 - PHARMASEAL STERILE WOUND CARE DRESSING (FDA 510(k) Clearance)

K884397 is an FDA 510(k) clearance for the PHARMASEAL STERILE WOUND CARE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 69 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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