Cleared Traditional

4 X 4 SPONGES, NON-STERILE

K870282 · The Medical Group, Inc. · General & Plastic Surgery

Feb 1987

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K870282 is an FDA 510(k) clearance for the 4 X 4 SPONGES, NON-STERILE, a Gauze / Sponge,nonresorbable For External Use (Class I — General Controls, product code NAB), submitted by The Medical Group, Inc. (Reno, US). The FDA issued a Cleared decision on February 24, 1987, 28 days after receiving the submission on January 27, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4014.

Submission Details

510(k) Number	K870282 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 1987
Decision Date	February 24, 1987
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—