K140389 - CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 (FDA 510(k) Clearance)

K140389 is an FDA 510(k) clearance for the CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Entrotech Life Sciences, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 7, 2014 after a review of 266 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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