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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 K991519
Device Name AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
AMERIWATER
1257 STANLEY AVE.
DAYTON,  OH  45404
Applicant Contact SANDRA E MONSMAN
Correspondent
AMERIWATER
1257 STANLEY AVE.
DAYTON,  OH  45404
Correspondent Contact SANDRA E MONSMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/30/1999
Decision Date 04/14/2000
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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