Device Classification Name |
Prosthesis, Penile
|
510(k) Number |
K896941 |
Device Name |
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
11001 BREN RD. EAST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
DENNIS TOUSSAINT |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
11001 BREN RD. EAST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
DENNIS TOUSSAINT |
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 12/13/1989 |
Decision Date | 03/06/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|