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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pad, Heating, Powered
510(k) Number K881800
Device Name BCS NO. 1, BODY CARE SYSTEM
Applicant
M & A Vertrieb, Liske Und Methling GM
Horwarthstrabe 11
8000 Munchen 40
West Germany,  DE
Applicant Contact LISKE
Correspondent
M & A Vertrieb, Liske Und Methling GM
Horwarthstrabe 11
8000 Munchen 40
West Germany,  DE
Correspondent Contact LISKE
Regulation Number890.5740
Classification Product Code
IRT  
Date Received04/27/1988
Decision Date 11/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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