Device Classification Name |
Prosthesis, Penile
|
510(k) Number |
K860517 |
Device Name |
MENTOR CORPORAL DILATORS |
Applicant |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Applicant Contact |
KAREN EDWARDS |
Correspondent |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
KAREN EDWARDS |
Regulation Number | 876.3630 |
Classification Product Code |
|
Date Received | 02/11/1986 |
Decision Date | 03/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|