Cleared Traditional

K915591 - STERILE GAUZE PADS
(FDA 510(k) Clearance)

K915591 · Eagle Medical, Inc. · General & Plastic Surgery device

Jan 1993

Decision

411d

Days

Class 1

Risk

K915591 is an FDA 510(k) clearance for the STERILE GAUZE PADS. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).

Submitted by Eagle Medical, Inc. (Bridgeton, US). The FDA issued a Cleared decision on January 27, 1993, 411 days after receiving the submission on December 13, 1991.

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

Submission Details

510(k) Number	K915591 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 1991
Decision Date	January 27, 1993
Days to Decision	411 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement