The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Burnett Tmj Appliance.
| Device ID | K870243 |
| 510k Number | K870243 |
| Device Name: | BURNETT TMJ APPLIANCE |
| Classification | Cephalometer |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Ruey C Dempsey |
| Correspondent | Ruey C Dempsey MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258009339 | K870243 | 000 |
| 00616258009322 | K870243 | 000 |
| 10616258009312 | K870243 | 000 |