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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 K953904
Device Name SARNS 9000 UNIVERSAL ROLLER PUMP
Applicant
3M HEALTH CARE, LTD.
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact CHERYL ROSENBERG
Correspondent
3M HEALTH CARE, LTD.
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact CHERYL ROSENBERG
Regulation Number870.4370
Classification Product Code
DWB  
Date Received08/18/1995
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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