Device Classification Name |
tank, holding, dialysis
|
510(k) Number |
K093641 |
Device Name |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
Applicant |
TANGO3, LLC |
141A CITIZENS BLVD |
SIMPSONVILLE,
KY
40067
|
|
Applicant Contact |
LORI HOLDER |
Correspondent |
TANGO3, LLC |
141A CITIZENS BLVD |
SIMPSONVILLE,
KY
40067
|
|
Correspondent Contact |
LORI HOLDER |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 11/24/2009 |
Decision Date | 12/08/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|