The following data is part of a De Novo classification by Sinclair Pharmaceuticals Limited with the FDA for Decapinol Oral Rinse.
DeNovo ID | DEN050001 |
Device Name: | DECAPINOL ORAL RINSE |
Classification | Rinse, Oral, Antibacterial (by Physical Means) |
Applicant | SINCLAIR PHARMACEUTICALS LIMITED borough Road Godalming, GB |
Contact | Michael Killeen |
Product Code | NTO |
CFR Regulation Number | 872.5580 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | K041482 |
Review Advisory Board | Dental |
Classification Advisory | Dental |
Type | Post-NSE |
Date Received | 2005-01-24 |
Decision Date | 2005-04-18 |
Reclassification Order: | Reclassification Order |