The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Sst Saliva Supporting Tablets.
| Device ID | K023046 |
| 510k Number | K023046 |
| Device Name: | SST SALIVA SUPPORTING TABLETS |
| Classification | Stains, Chemical Solution |
| 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 | LED |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-12 |
| Decision Date | 2002-12-02 |
| Summary: | summary |