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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 K992910
Device Name AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
Applicant
MEDTRONIC VASCULAR
4633 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Applicant Contact DEBRA KRIDNER
Correspondent
MEDTRONIC VASCULAR
4633 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Correspondent Contact DEBRA KRIDNER
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received08/30/1999
Decision Date 09/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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