The following data is part of a premarket notification filed by Oxyfresh with the FDA for Oxyfresh Oxycare 3000.
| Device ID | K910832 |
| 510k Number | K910832 |
| Device Name: | OXYFRESH OXYCARE 3000 |
| Classification | Unit, Oral Irrigation |
| Applicant | OXYFRESH P.O. BOX 3723 Spokane, WA 99220 |
| Contact | Vernon A Nord |
| Correspondent | Vernon A Nord OXYFRESH P.O. BOX 3723 Spokane, WA 99220 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-04-17 |