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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K897039
Device Name SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
Applicant
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JAMES BALUN
Correspondent
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JAMES BALUN
Regulation Number870.4240
Classification Product Code
DTR  
Date Received12/18/1989
Decision Date 03/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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