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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K915183
Device Name SARNS 8000 MODULAR PERFUSION SYSTEM
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JAMES BALUN
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JAMES BALUN
Regulation Number870.4220
Classification Product Code
DTQ  
Subsequent Product Codes
DTW   DWA   DWB   DWC   KRI  
KRL  
Date Received11/18/1991
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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