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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K991137
Device Name ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
Applicant
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact LYNN LUEDERS
Correspondent
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact LYNN LUEDERS
Regulation Number870.4240
Classification Product Code
DTR  
Date Received04/05/1999
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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