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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K962320
Device Name S3 CARDIOPLEGIA CONTROL
Applicant
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE MINEAR
Correspondent
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE MINEAR
Regulation Number870.4240
Classification Product Code
DTR  
Date Received06/17/1996
Decision Date 01/10/1997
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
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