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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 K122827
Device Name AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact MARY E DONLIN
Correspondent
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact MARY E DONLIN
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received09/14/2012
Decision Date 12/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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