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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 K991495
Device Name FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
Applicant
FLUID PROCESS SYSTEMS, INC.
998-A PEYTON RD.
EL PASO,  TX  79927
Applicant Contact STEPHEN C HAMBRIC
Correspondent
FLUID PROCESS SYSTEMS, INC.
998-A PEYTON RD.
EL PASO,  TX  79927
Correspondent Contact STEPHEN C HAMBRIC
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/28/1999
Decision Date 08/28/2000
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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