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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Electrical
510(k) Number K883613
Device Name OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.
Applicant
Stierlen-Maquet AG
Kehler Strasse 31
7550 Rastatt
West Germany,  GR
Applicant Contact SCHNELLE
Correspondent
Stierlen-Maquet AG
Kehler Strasse 31
7550 Rastatt
West Germany,  GR
Correspondent Contact SCHNELLE
Regulation Number878.4960
Classification Product Code
GDC  
Date Received08/22/1988
Decision Date 09/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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