The following data is part of a premarket notification filed by Surgitek with the FDA for Flexi-flate Penile Implant.
| Device ID | K834347 |
| 510k Number | K834347 |
| Device Name: | FLEXI-FLATE PENILE IMPLANT |
| Classification | Prosthesis, Penile |
| Applicant | SURGITEK 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 | 1983-12-13 |
| Decision Date | 1984-04-02 |