Cleared Traditional

K873377 - CLOSED CHEST DRAINAGE SET W/SUTURES
(FDA 510(k) Clearance)

K873377 · Gish Biomedical, Inc. · General & Plastic Surgery

Oct 1987

Decision

65d

Days

Class 1

Risk

K873377 is an FDA 510(k) clearance for the CLOSED CHEST DRAINAGE SET W/SUTURES, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 28, 1987, 65 days after receiving the submission on August 24, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K873377 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 1987
Decision Date	October 28, 1987
Days to Decision	65 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—