The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Salinum, Orclair.
| Device ID | K024148 |
| 510k Number | K024148 |
| Device Name: | SALINUM, ORCLAIR |
| Classification | Saliva, Artificial |
| Applicant | SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
| Contact | Denise Swift |
| Correspondent | Denise Swift SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
| 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 | 2002-12-16 |
| Decision Date | 2003-09-15 |
| Summary: | summary |