Device Classification Name |
prosthesis, penile
|
510(k) Number |
K040959 |
Device Name |
MENTOR GENESIS PENILE PROSTHESIS |
Applicant |
MENTOR CORP. |
201 MENTOR DR. |
SANTA BARBARA,
CA
93111
|
|
Applicant Contact |
DONNA A CRAWFORD |
Correspondent |
MENTOR CORP. |
201 MENTOR DR. |
SANTA BARBARA,
CA
93111
|
|
Correspondent Contact |
DONNA A CRAWFORD |
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 04/13/2004 |
Decision Date | 10/29/2004 |
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
|
|
|