The following data is part of a premarket notification filed by Sinclair Pharmaceuticals Limited with the FDA for Sinclair Oral Rinse.
| Device ID | K053166 |
| 510k Number | K053166 |
| Device Name: | SINCLAIR ORAL RINSE |
| Classification | Rinse, Oral, Antibacterial (by Physical Means) |
| Applicant | SINCLAIR PHARMACEUTICALS LIMITED BOROUGH ROAD Godalming, Surrey, GB |
| Contact | Michael Killeen |
| Correspondent | Michael Killeen SINCLAIR PHARMACEUTICALS LIMITED BOROUGH ROAD Godalming, Surrey, GB |
| Product Code | NTO |
| CFR Regulation Number | 872.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-05-17 |
| Summary: | summary |