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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K050952
Device Name HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact LYNN LUEDERS
Correspondent
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact LYNN LUEDERS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/15/2005
Decision Date 01/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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