The following data is part of a premarket notification filed by Osspray Ltd with the FDA for Osspray Sylc Cr.
| Device ID | K103114 |
| 510k Number | K103114 |
| Device Name: | OSSPRAY SYLC CR |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | OSSPRAY LTD HODGKIN BUILDING KINGS COLLEGE LONDON London, GB Se1 1ul |
| Contact | Ian Thompson |
| Correspondent | Ian Thompson OSSPRAY LTD HODGKIN BUILDING KINGS COLLEGE LONDON London, GB Se1 1ul |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2011-03-14 |
| Summary: | summary |