Device Classification Name |
Prosthesis, Penile
|
510(k) Number |
K912344 |
Device Name |
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS |
Applicant |
DACOMED CORP. |
1701 E. 79TH ST., STE. 17 |
MINNEAPOLIS,
MN
55425
|
|
Applicant Contact |
MARY M.WILEN |
Correspondent |
DACOMED CORP. |
1701 E. 79TH ST., STE. 17 |
MINNEAPOLIS,
MN
55425
|
|
Correspondent Contact |
MARY M.WILEN |
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 05/28/1991 |
Decision Date | 10/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|