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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Prebypass, Cardiopulmonary Bypass
510(k) Number K900672
Device Name PREBYPASS FILTER, CAT. NO. FPB-5
Applicant
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Applicant Contact J BUCKLEIN
Correspondent
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Correspondent Contact J BUCKLEIN
Regulation Number870.4280
Classification Product Code
KRJ  
Date Received02/13/1990
Decision Date 04/03/1990
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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