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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor and/or control, level sensing, cardiopulmonary bypass
510(k) Number K900815
Device Name SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
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 Number870.4340
Classification Product Code
DTW  
Date Received02/21/1990
Decision Date 05/09/1990
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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