Cleared Traditional

OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.

K883613 · Stierlen-Maquet AG · General & Plastic Surgery

Sep 1988

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K883613 is an FDA 510(k) clearance for the OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO., a Table, Operating-room, Electrical (Class I — General Controls, product code GDC), submitted by Stierlen-Maquet AG (West Germany, GR). The FDA issued a Cleared decision on September 15, 1988, 24 days after receiving the submission on August 22, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K883613 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 1988
Decision Date	September 15, 1988
Days to Decision	24 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—