The following data is part of a premarket notification filed by Bio-x Healthcare S.a. with the FDA for Bioxtra Moisturizing Gel.
| Device ID | K072306 |
| 510k Number | K072306 |
| Device Name: | BIOXTRA MOISTURIZING GEL |
| Classification | Saliva, Artificial |
| Applicant | BIO-X HEALTHCARE S.A. 1601 K STREET NW Washington, DC 20036 |
| Contact | Emalee Murphy |
| Correspondent | Emalee Murphy BIO-X HEALTHCARE S.A. 1601 K STREET NW Washington, DC 20036 |
| 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 | 2007-08-17 |
| Decision Date | 2007-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425005127517 | K072306 | 000 |