Device Classification Name |
prosthesis, penile
|
510(k) Number |
K953640 |
Device Name |
DUNA II 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 | 08/04/1995 |
Decision Date | 10/27/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|