The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Malleable Penile Prosthesis.
| Device ID | K831660 |
| 510k Number | K831660 |
| Device Name: | AMS MALLEABLE PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-08-08 |