The following data is part of a premarket notification filed by Passion For Life Healthcare (uk) Limited with the FDA for Oral Device Oa, Oral Device S.
| Device ID | K181396 |
| 510k Number | K181396 |
| Device Name: | Oral Device OA, Oral Device S |
| Classification | Device, Anti-snoring |
| Applicant | Passion For Life Healthcare (UK) Limited Pioneer House, Pioneer Business Park North Road Ellesmere Port, GB Ch65 1ad |
| Contact | Paul Earps |
| Correspondent | Paul Dryden Passion For Life Healthcare (UK) Limited Pioneer House, Pioneer Business Park North Road Ellesmere Port, GB Ch65 1ad |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15035883000917 | K181396 | 000 |