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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tank, Holding, Dialysis
510(k) Number K140984
Device Name TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
Applicant
Tango3, LLC
141 Citizens Blvd.
Simpsonville,  KY  40067
Applicant Contact LORI HOLDER
Correspondent
Tango3, LLC
141 Citizens Blvd.
Simpsonville,  KY  40067
Correspondent Contact LORI HOLDER
Regulation Number876.5820
Classification Product Code
FIN  
Date Received04/16/2014
Decision Date 01/12/2015
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
Predetermined Change
Control Plan Authorized		 No
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