RACEGEL
Cord, Retraction
SEPTODONT
The following data is part of a premarket notification filed by Septodont with the FDA for Racegel.
Pre-market Notification Details
| Device ID | K093711 |
| 510k Number | K093711 |
| Device Name: | RACEGEL |
| Classification | Cord, Retraction |
| Applicant | SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Contact | Wayne Matelski, Esq |
| Correspondent | Wayne Matelski, Esq SEPTODONT 1050 CONNECTICUT AVE., NW Washington, DC 20036 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-02-17 |
Trademark Results [RACEGEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RACEGEL 79086100 4033306 Dead/Cancelled |
Monsieur Henri Numa Marcel SCHILLER 2010-07-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.