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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 K933481
Device Name SORIN MONOLYTH VENOUS RESERVOIR
Applicant
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92614
Applicant Contact DAVID TAYLOR
Correspondent
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92614
Correspondent Contact DAVID TAYLOR
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/30/1993
Decision Date 11/02/1993
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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