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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 K041163
Device Name ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Applicant
Isopure, Corp.
129 Citizens Blvd.
Simpsonville,  KY  40067
Applicant Contact KEVIN GILLESPIE
Correspondent
Isopure, Corp.
129 Citizens Blvd.
Simpsonville,  KY  40067
Correspondent Contact KEVIN GILLESPIE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received05/03/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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