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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 K823451
Device Name CLEAR CARDIOPLEJIA DELIVERY SYSTEM
Applicant
3M HEALTH CARE, SARNS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
3M HEALTH CARE, SARNS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4240
Classification Product Code
DTR  
Date Received11/17/1982
Decision Date 01/14/1983
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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