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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 K993806
Device Name DIALGUARD ENDOTOXIN REMOVAL DEVICE
Applicant
CLARIGEN, INC.
5922 FARNSWORTH COURT
CARLSBAD,  CA  92008
Applicant Contact EDIT HEGYI
Correspondent
CLARIGEN, INC.
5922 FARNSWORTH COURT
CARLSBAD,  CA  92008
Correspondent Contact EDIT HEGYI
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/09/1999
Decision Date 08/14/2000
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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