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 |