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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 K922933
Device Name SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
Applicant
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Applicant Contact LORI E ADELS
Correspondent
Sorin Biomedica, Fiat, USA, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Correspondent Contact LORI E ADELS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received06/18/1992
Decision Date 11/30/1992
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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