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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K990103
Device Name MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
Applicant
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92614
Applicant Contact LYNNE LEONARD
Correspondent
Sorin Biomedical, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92614
Correspondent Contact LYNNE LEONARD
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received01/12/1999
Decision Date 11/05/1999
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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