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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 K041884
Device Name MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
MUELLER WATER CONDITIONING, INC.
1500 SHERWOOD FOREST DR.
HOUSTON,  TX  77043 -3899
Applicant Contact DAVID W MUELLER
Correspondent
MUELLER WATER CONDITIONING, INC.
1500 SHERWOOD FOREST DR.
HOUSTON,  TX  77043 -3899
Correspondent Contact DAVID W MUELLER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received07/12/2004
Decision Date 02/28/2005
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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