Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K181643 |
Device Name |
SmartBag (SmartPouch) |
Applicant |
11 Health Technologies Limited |
The Kinetic Business Centre, Theobald Street |
Borehamwood,
GB
WD6 4PJ
|
|
Applicant Contact |
Michael Seres |
Correspondent |
11 Health Technologies Limited |
The Kinetic Business Centre, Theobald Street |
Borehamwood,
GB
WD6 4PJ
|
|
Correspondent Contact |
Priya Woodun |
Regulation Number | 876.5900
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/22/2018 |
Decision Date | 11/16/2018 |
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
|
|
|