510(k) K053166
- Device
- SINCLAIR ORAL RINSE
- Applicant
- SINCLAIR PHARMACEUTICALS LIMITED
- 510(k) number
- K053166
- Product code
- NTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-17
- Date received
- 2005-11-14
- Regulation
- 872.5580
- Classification name
- Rinse, Oral, Antibacterial (by Physical Means)
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL KILLEEN
- Address
- Borough Rd. Godalming, Surrey GB
FDA Registration Numbers#
- 3003311293
Source Documents#
Other 510(k) Records For Product Code NTO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN050001 | DECAPINOL ORAL RINSE | Sinclair Pharmaceuticals Limited | 2005-04-18 |
Legacy Summary#
summary
FDA Review#
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