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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 K900601
Device Name SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
Applicant
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact SIMPSON, MD
Correspondent
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact SIMPSON, MD
Regulation Number870.4360
Classification Product Code
KFM  
Date Received02/08/1990
Decision Date 03/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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