The following data is part of a premarket notification filed by Laboratoires Carilene S.a.s. with the FDA for Tgo Spray.
| Device ID | K051812 |
| 510k Number | K051812 |
| Device Name: | TGO SPRAY |
| Classification | Saliva, Artificial |
| Applicant | LABORATOIRES CARILENE S.A.S. 1800 MASSACHUSETTS AVE., NW Washington, DC 20036 |
| Contact | Emalee Murphy |
| Correspondent | Emalee Murphy LABORATOIRES CARILENE S.A.S. 1800 MASSACHUSETTS AVE., 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 | 2005-07-05 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10196852643216 | K051812 | 000 |