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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reservoir, blood, cardiopulmonary bypass
510(k) Number K122914
Device Name AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact JULIA A NELSON
Correspondent
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact JULIA A NELSON
Regulation Number870.4400
Classification Product Code
DTN  
Date Received09/21/2012
Decision Date 01/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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