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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K964907
Device Name VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
Applicant
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713 -9503
Applicant Contact RICHARD J DERISIO
Correspondent
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92713 -9503
Correspondent Contact RICHARD J DERISIO
Regulation Number870.4400
Classification Product Code
DTN  
Date Received12/09/1996
Decision Date 08/21/1997
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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