Device Classification Name |
pouch, colostomy
|
510(k) Number |
K083785 |
Device Name |
VITALA CONTINENCE CONTROL DEVICE |
Applicant |
CONVATEC |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Applicant Contact |
MARILYN KONICKY |
Correspondent |
CONVATEC |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Correspondent Contact |
MARILYN KONICKY |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 12/19/2008 |
Decision Date | 04/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00809406
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|