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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 K983126
Device Name FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
Applicant
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Applicant Contact MARK MURPHY
Correspondent
MINNTECH CORP.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55447
Correspondent Contact MARK MURPHY
Regulation Number876.5665
Classification Product Code
FIP  
Date Received09/08/1998
Decision Date 03/08/1999
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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