The following data is part of a premarket notification filed by Osbon Medical Systems, Ltd. with the FDA for Stayerec System(tm).
| Device ID | K901318 |
| 510k Number | K901318 |
| Device Name: | STAYEREC SYSTEM(TM) |
| Classification | Device, External Penile Rigidity |
| Applicant | OSBON MEDICAL SYSTEMS, LTD. POST OFFICE BOX 1478 Augusta, GA 30903 |
| Contact | Bettye E Griner |
| Correspondent | Bettye E Griner OSBON MEDICAL SYSTEMS, LTD. POST OFFICE BOX 1478 Augusta, GA 30903 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-21 |
| Decision Date | 1990-05-04 |