K822990 - CONVERTORS PRIMARY WOUND DRESSING II (FDA 510(k) Clearance)

K822990 is an FDA 510(k) clearance for the CONVERTORS PRIMARY WOUND DRESSING II. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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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