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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 K860673
Device Name OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
Applicant
AMERICAN BENTLEY
17502 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact DONALD A RAIBLE
Correspondent
AMERICAN BENTLEY
17502 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received02/24/1986
Decision Date 06/26/1986
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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