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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 K010592
Device Name AQUA WATER TREATMENT FOR HEMODIALYSIS
Applicant
AQUA WATER TREATMENT, INC.
8195 EAST BAY BLVD.
NAVARRE,  FL  32566
Applicant Contact ANTHONY WEATHERS
Correspondent
AQUA WATER TREATMENT, INC.
8195 EAST BAY BLVD.
NAVARRE,  FL  32566
Correspondent Contact ANTHONY WEATHERS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received02/28/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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