The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Erectek Tm External Erection Device.
| Device ID | K905015 |
| 510k Number | K905015 |
| Device Name: | SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE |
| Classification | Device, External Penile Rigidity |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Steve Aperavich |
| Correspondent | Steve Aperavich SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1990-12-28 |