The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for The Inflatable Penile Prosthesis.
| Device ID | K821628 |
| 510k Number | K821628 |
| Device Name: | THE INFLATABLE PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-02 |
| Decision Date | 1982-08-10 |