Cleared Traditional

MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER

K871464 · Medgroup Enterprises, Inc. · Dental

Apr 1987

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K871464 is an FDA 510(k) clearance for the MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER, a Cotton, Roll (Class I — General Controls, product code EFN), submitted by Medgroup Enterprises, Inc. (Burbank, US). The FDA issued a Cleared decision on April 30, 1987, 16 days after receiving the submission on April 14, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number	K871464 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 1987
Decision Date	April 30, 1987
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—