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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, blood, cardiopulmonary bypass, roller type
510(k) Number K780942
Device Name BLOOD PUMP MODEL 7000
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 Number870.4370
Classification Product Code
DWB  
Date Received06/07/1978
Decision Date 06/19/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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