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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 K974899
Device Name GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
Applicant
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215 -4498
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215 -4498
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/30/1997
Decision Date 09/23/1998
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
Recalls CDRH Recalls
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