Device Classification Name |
Prosthesis, Penile
|
510(k) Number |
K821628 |
Device Name |
THE INFLATABLE PENILE PROSTHESIS |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.3630
|
Classification Product Code |
|
Date Received | 06/02/1982 |
Decision Date | 08/10/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|