SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP (K984204) - FDA 510(k) Clearance

K984204 is an FDA 510(k) clearance for the SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum International, LLC (Lakemont, US). The FDA issued a Cleared decision on March 19, 2007 after a review of 3037 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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