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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 K981680
Device Name ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
Applicant
DAYTON WATER SYSTEMS
1288 MCCOOK AVE.
DAYTON,  OH  45404
Applicant Contact CINDY HELTON
Correspondent
DAYTON WATER SYSTEMS
1288 MCCOOK AVE.
DAYTON,  OH  45404
Correspondent Contact CINDY HELTON
Regulation Number876.5665
Classification Product Code
FIP  
Date Received05/13/1998
Decision Date 12/31/1998
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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