The following data is part of a premarket notification filed by Septodont with the FDA for Rtr Syringe.
| Device ID | K063634 |
| 510k Number | K063634 |
| Device Name: | RTR SYRINGE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-06 |
| Decision Date | 2007-05-11 |