The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Glandosane (salivart) Synthetic Saliva.
| Device ID | K874106 |
| 510k Number | K874106 |
| Device Name: | GLANDOSANE (SALIVART) SYNTHETIC SALIVA |
| Classification | Saliva, Artificial |
| Applicant | FRESENIUS USA, INC. VERWALTUNG: BORKENBERG 14 6370 OBERURSEL/TAUNUS 1 Germany, DE |
| Contact | Eric Holst |
| Correspondent | Eric Holst FRESENIUS USA, INC. VERWALTUNG: BORKENBERG 14 6370 OBERURSEL/TAUNUS 1 Germany, DE |
| 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 | 1987-10-09 |
| Decision Date | 1988-04-15 |