Device Classification Name |
prosthesis, penile
|
510(k) Number |
K082006 |
Device Name |
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
STEPHANIE GEORGE |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
STEPHANIE GEORGE |
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 07/15/2008 |
Decision Date | 10/20/2008 |
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
|
|
|