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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, Non-Roller Type
510(k) Number K915363
Device Name SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
Applicant
3M HEALTH CARE, LTD.
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact NANCY P ATWOOD
Correspondent
3M HEALTH CARE, LTD.
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact NANCY P ATWOOD
Regulation Number870.4360
Classification Product Code
KFM  
Date Received11/27/1991
Decision Date 07/28/1993
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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