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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 K981085
Device Name GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
Applicant
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Applicant Contact WILLIAM M TOWNSEND
Correspondent
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Correspondent Contact WILLIAM M TOWNSEND
Regulation Number876.5665
Classification Product Code
FIP  
Date Received03/25/1998
Decision Date 05/18/1998
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
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