510(k) DEN050001
- Device
- DECAPINOL ORAL RINSE
- Applicant
- Sinclair Pharmaceuticals Limited
- 510(k) number
- DEN050001
- Product code
- NTO
- Decision
- Unknown (DENG)
- Decision date
- 2005-04-18
- Date received
- 2005-01-24
- Regulation
- 872.5580
- Classification name
- Rinse, Oral, Antibacterial (By Physical Means)
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- MICHAEL KILLEEN
- Address
- Borough Rd. Godalming, Surrey GB
FDA Registration Numbers#
- 3003311293
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NTO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053166 | SINCLAIR ORAL RINSE | Sinclair Pharmaceuticals Limited | 2006-05-17 |