The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Malleable Penile Prosthesis.
| Device ID | K843280 |
| 510k Number | K843280 |
| Device Name: | MALLEABLE PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-10-24 |