The following data is part of a premarket notification filed by Osbon Medical Systems, Ltd. with the FDA for Erecaid(r) System Plus.
| Device ID | K912736 |
| 510k Number | K912736 |
| Device Name: | ERECAID(R) SYSTEM PLUS |
| Classification | Device, External Penile Rigidity |
| Applicant | OSBON MEDICAL SYSTEMS, LTD. POST OFFICE BOX 1478 Augusta, GA 30903 |
| Contact | Julian W Osbon |
| Correspondent | Julian W Osbon 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 | 1991-06-21 |
| Decision Date | 1991-08-12 |