The following data is part of a premarket notification filed by Elevate Oral Care with the FDA for Elevate Moisturizing Spray.
| Device ID | K150074 |
| 510k Number | K150074 |
| Device Name: | Elevate Moisturizing Spray |
| Classification | Saliva, Artificial |
| Applicant | ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach, FL 33411 |
| Contact | Steve Pardue |
| Correspondent | Steve Pardue ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach, FL 33411 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-14 |
| Decision Date | 2015-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006635 | K150074 | 000 |
| 00858290006666 | K150074 | 000 |
| 00858290006741 | K150074 | 000 |
| 00858290006710 | K150074 | 000 |
| 00858290006703 | K150074 | 000 |
| 00858290006871 | K150074 | 000 |
| 00858290006895 | K150074 | 000 |