The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Mandibular Tray.
| Device ID | K821904 |
| 510k Number | K821904 |
| Device Name: | XOMED MANDIBULAR TRAY |
| Classification | Prosthesis, Facial, Mandibular Implant |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | JAZ |
| CFR Regulation Number | 874.3695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-28 |
| Decision Date | 1982-07-26 |