SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN (K983249) - FDA 510(k) Clearance

K983249 is an FDA 510(k) clearance for the SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Euromed, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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