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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 K093608
Device Name GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
Applicant
GAMBRO RENAL PRODUCTS, INC.
14143 DENVER WEST PARKWAY
SUITE 400
LAKEWOOD,  CO  80401
Applicant Contact KAE MILLER
Correspondent
GAMBRO RENAL PRODUCTS, INC.
14143 DENVER WEST PARKWAY
SUITE 400
LAKEWOOD,  CO  80401
Correspondent Contact KAE MILLER
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/20/2009
Decision Date 07/29/2010
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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