K072956 - MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY (FDA 510(k) Clearance)

K072956 is an FDA 510(k) clearance for the MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 19 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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