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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K884893
Device Name CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
Applicant
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Applicant Contact GEORGE G SIPOSS
Correspondent
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Correspondent Contact GEORGE G SIPOSS
Regulation Number870.4200
Classification Product Code
KRI  
Date Received11/22/1988
Decision Date 01/30/1989
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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