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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 K811678
Device Name GAMBRO WATER PURIFICATION MONITOR WRD
Applicant
GAMBRO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GAMBRO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/15/1981
Decision Date 07/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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