Device Classification Name |
device, incontinence, urosheath type, sterile
|
510(k) Number |
K950690 |
Device Name |
PROSYS URIHESICE SYSTEM NL |
Applicant |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Applicant Contact |
MARILYN DREYLING |
Correspondent |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Correspondent Contact |
MARILYN DREYLING |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 02/14/1995 |
Decision Date | 03/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|