HYPO CLENZ WOUND WASH MODEL 100 PPM (K100948) - FDA 510(k) Clearance

K100948 is an FDA 510(k) clearance for the HYPO CLENZ WOUND WASH MODEL 100 PPM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nevoa Life Sciences, LLC (Carmichael, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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