Cleared Traditional

K872759 - AQUATULLE FINE MESH NON-ADHERING DRESSING (FDA 510(k) Clearance)

Sep 1987
Decision
53d
Days
Risk

K872759 is an FDA 510(k) clearance for the AQUATULLE FINE MESH NON-ADHERING DRESSING. This device is classified as a Gauze/sponge, Internal.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on September 4, 1987, 53 days after receiving the submission on July 13, 1987.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K872759 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 13, 1987
Decision Date September 04, 1987
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code EFQ — Gauze/sponge, Internal
Device Class