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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 K153329
Device Name MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
Applicant
MED-TECH WATER SYSTEMS INC
1755 WOOLNER AVENUE SUITE B
FAIRFIELD,  CA  94533
Applicant Contact BRIAN C KIM
Correspondent
MED-TECH WATER SYSTEMS INC
1755 WOOLNER AVENUE SUITE B
FAIRFIELD,  CA  94533
Correspondent Contact BRIAN C KIM
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/19/2015
Decision Date 08/04/2016
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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