The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Virilis Penile Prosthesis.
| Device ID | K983015 |
| 510k Number | K983015 |
| Device Name: | VIRILIS PENILE PROSTHESIS |
| Classification | Prosthesis, Penis, Rigid Rod |
| Applicant | SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Contact | T.jan Varner |
| Correspondent | T.jan Varner SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Product Code | FTQ |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1999-02-05 |