K894226 - SILASTIC SOFT SHEETING (FDA 510(k) Clearance)

K894226 is an FDA 510(k) clearance for the SILASTIC SOFT SHEETING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 198 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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