The following data is part of a premarket notification filed by Ospray, Ltd. with the FDA for Osspray Cleaning Compound.
| Device ID | K062502 |
| 510k Number | K062502 |
| Device Name: | OSSPRAY CLEANING COMPOUND |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | OSPRAY, LTD. 700 THIRTEENTH STREET NW SUITE 1200 Washington, DC 20005 |
| Contact | Carmelina G Allis |
| Correspondent | Carmelina G Allis OSPRAY, LTD. 700 THIRTEENTH STREET NW SUITE 1200 Washington, DC 20005 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2006-12-15 |
| Summary: | summary |