The following data is part of a premarket notification filed by Osbon Medical Systems, Ltd. with the FDA for Osbon Personal Lubricant.
| Device ID | K895406 |
| 510k Number | K895406 |
| Device Name: | OSBON PERSONAL LUBRICANT |
| Classification | Lubricant, Patient |
| Applicant | OSBON MEDICAL SYSTEMS, LTD. POST OFFICE BOX 1478 Augusta, GA 30903 |
| Contact | Bettye Griner |
| Correspondent | Bettye Griner OSBON MEDICAL SYSTEMS, LTD. POST OFFICE BOX 1478 Augusta, GA 30903 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-12-01 |