The following data is part of a premarket notification filed by Bio Cosmetics, S.l. with the FDA for Xerostom Saliva Substitute Gel.
| Device ID | K142657 |
| 510k Number | K142657 |
| Device Name: | XEROSTOM SALIVA SUBSTITUTE GEL |
| Classification | Saliva, Artificial |
| Applicant | BIO COSMETICS, S.L. CALLE ARAQUIL, 11 Madrid, ES 28023 |
| Contact | Susana Sardon |
| Correspondent | Manoj Zacharias LIBERTY MANAGEMENT GROUP LTD 2871 COASTAL DRIVE Aurora, IL 60503 |
| 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 | 2014-09-18 |
| Decision Date | 2015-09-14 |