The following data is part of a premarket notification filed by Myofunctional Research Corp. Pty. Ltd. with the FDA for The Tmj Appliance.
Device ID | K924974 |
510k Number | K924974 |
Device Name: | THE TMJ APPLIANCE |
Classification | Positioner, Tooth, Preformed |
Applicant | MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
Contact | Chris Farrell |
Correspondent | Chris Farrell MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
Product Code | KMY |
CFR Regulation Number | 872.5525 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-30 |
Decision Date | 1993-06-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THE TMJ APPLIANCE 88935150 not registered Live/Pending |
Myofunctional Research Corporation Pty.Limited 2020-05-27 |