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 |