Cleared Traditional

K870283 - 3 X 3 SPONGES, NON-STERILE
(FDA 510(k) Clearance)

K870283 · The Medical Group, Inc. · General & Plastic Surgery device

Feb 1987

Decision

28d

Days

Class 1

Risk

K870283 is an FDA 510(k) clearance for the 3 X 3 SPONGES, NON-STERILE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4014.

Submission Details

510(k) Number	K870283 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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	—