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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 K900640
Device Name MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
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 Received02/09/1990
Decision Date 04/20/1990
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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