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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 K853516
Device Name SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact MARSHALL SMITH
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact MARSHALL SMITH
Regulation Number870.4240
Classification Product Code
DTR  
Date Received08/22/1985
Decision Date 11/14/1985
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
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