The following data is part of a premarket notification filed by Tango3, Llc with the FDA for Tango3 Water Storage Tank With Ozone Disinfection System.
| Device ID | K093641 |
| 510k Number | K093641 |
| Device Name: | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | TANGO3, LLC 141A CITIZENS BLVD Simpsonville, KY 40067 |
| Contact | Lori Holder |
| Correspondent | Lori Holder TANGO3, LLC 141A CITIZENS BLVD Simpsonville, KY 40067 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-24 |
| Decision Date | 2010-12-08 |
| Summary: | summary |