REVERA WOUND CARE, MODEL MDW0060 (K070463) - FDA 510(k) Clearance

K070463 is an FDA 510(k) clearance for the REVERA WOUND CARE, MODEL MDW0060. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Revalesio Corporation (Tacoma, US). The FDA issued a Cleared decision on May 7, 2008 after a review of 446 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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