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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K945136
Device Name RENAGUARD DIALYSATE FILTER
Applicant
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Applicant Contact LEROY J FISCHBACH
Correspondent
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/20/1994
Decision Date 02/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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