The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Racestyptine.
| Device ID | K884653 |
| 510k Number | K884653 |
| Device Name: | RACESTYPTINE |
| Classification | Burnisher, Operative |
| Applicant | SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT WASHINGTON SQUARE 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-01-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RACESTYPTINE 73570203 not registered Dead/Abandoned |
MANTEL, ANNY 1985-11-25 |
![]() RACESTYPTINE 73230429 1157835 Live/Registered |
Mantel; Anny 1979-09-07 |