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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 K043344
Device Name DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
Applicant
Dialysis Services, Inc.
3620 Kelton Jackson Rd.
Springfield,  TN  37172
Applicant Contact MIKE STERLING
Correspondent
Dialysis Services, Inc.
3620 Kelton Jackson Rd.
Springfield,  TN  37172
Correspondent Contact MIKE STERLING
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/06/2004
Decision Date 03/23/2005
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
Predetermined Change
Control Plan Authorized		 No
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