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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K871131
Device Name SARNS 9000 HEART-LUNG CONSOLE
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JOSEPH W O'DONNELL
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JOSEPH W O'DONNELL
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received03/20/1987
Decision Date 05/21/1987
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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