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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 K964967
Device Name BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact RICHARD GOLDHABER
Correspondent
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact RICHARD GOLDHABER
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/10/1996
Decision Date 03/06/1997
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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