510(k) K093641

TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM by Tango3, LLC — Product Code FIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2010
Date Received
November 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type