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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 K003957
Device Name DIACLEAR ULTRAFILTER
Applicant
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Applicant Contact SUZANNE DENNIS
Correspondent
Gambro Renal Products
10810 W Collins Ave.
Lakewood,  CO  80215
Correspondent Contact SUZANNE DENNIS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/21/2000
Decision Date 11/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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