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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alarm, blood-pressure
510(k) Number K960916
Device Name SAMS 8000 CARDIOPLEGIA MONITOR
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact CHERYL ROSENBERG
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact CHERYL ROSENBERG
Regulation Number870.1100
Classification Product Code
DSJ  
Subsequent Product Codes
DSK   DWB  
Date Received03/06/1996
Decision Date 06/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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