The following data is part of a premarket notification filed by Zygomatics Ltd. with the FDA for Rapid Imf.
| Device ID | K030605 |
| 510k Number | K030605 |
| Device Name: | RAPID IMF |
| Classification | Lock, Wire, And Ligature, Intraoral |
| Applicant | ZYGOMATICS LTD. 20A MONTPELIER VALE London Se3 0ta, GB |
| Contact | Carol Macdonald |
| Correspondent | Carol Macdonald ZYGOMATICS LTD. 20A MONTPELIER VALE London Se3 0ta, GB |
| Product Code | DYX |
| CFR Regulation Number | 872.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-06-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RAPID IMF 78548025 3294770 Dead/Cancelled |
DEPUY SYNTHES, INC. 2005-01-14 |