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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 K984271
Device Name MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
Applicant
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact KAREN CROPPER
Correspondent
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact KAREN CROPPER
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received11/30/1998
Decision Date 03/09/1999
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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