KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (K070685) - FDA 510(k) Clearance

K070685 is an FDA 510(k) clearance for the KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 186 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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