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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K925661
Device Name STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
Applicant
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Applicant Contact DAVID TAYLOR
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Correspondent Contact DAVID TAYLOR
Regulation Number870.4205
Classification Product Code
KRL  
Date Received11/10/1992
Decision Date 05/18/1993
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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