Cleared Traditional

K924650 - GAUZE SPONGES
(FDA 510(k) Clearance)

K924650 · Dav-Mar Medical Products, Inc. · General & Plastic Surgery device

Jan 1993

Decision

118d

Days

Class 1

Risk

K924650 is an FDA 510(k) clearance for the GAUZE SPONGES. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).

Submitted by Dav-Mar Medical Products, Inc. (Commack, US). The FDA issued a Cleared decision on January 11, 1993, 118 days after receiving the submission on September 15, 1992.

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

Submission Details

510(k) Number	K924650 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 15, 1992
Decision Date	January 11, 1993
Days to Decision	118 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement