The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ceravital Ceramic Ear Canal Wall Prosth.
| Device ID | K813224 |
| 510k Number | K813224 |
| Device Name: | CERAVITAL CERAMIC EAR CANAL WALL PROSTH |
| Classification | Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | ESF |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-09 |
| Decision Date | 1982-04-21 |