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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K113845
Device Name TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact KEVIN T LAM
Correspondent
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact KEVIN T LAM
Regulation Number870.4290
Classification Product Code
DTL  
Subsequent Product Code
DWF  
Date Received12/28/2011
Decision Date 01/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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