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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 K042797
Device Name WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact ROD J RYLANDS
Correspondent
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Correspondent Contact ROD J RYLANDS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/08/2004
Decision Date 03/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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