The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Genesis Penile Prosthesis.
| Device ID | K040959 |
| 510k Number | K040959 |
| Device Name: | MENTOR GENESIS PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-13 |
| Decision Date | 2004-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932324809 | K040959 | 000 |
| 05708932324748 | K040959 | 000 |
| 05708932324687 | K040959 | 000 |