Cleared Traditional

K925590 - MULTI-TRAUMA DRESSING
(FDA 510(k) Clearance)

K925590 · Gam Industries, Inc. · General & Plastic Surgery device

Apr 1993

Decision

154d

Days

Class 1

Risk

K925590 is an FDA 510(k) clearance for the MULTI-TRAUMA DRESSING. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on April 8, 1993, 154 days after receiving the submission on November 5, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.

Submission Details

510(k) Number	K925590 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1992
Decision Date	April 08, 1993
Days to Decision	154 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement