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 |