The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Thermal Myringotomy System.
| Device ID | K820157 |
| 510k Number | K820157 |
| Device Name: | XOMED THERMAL MYRINGOTOMY SYSTEM |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-19 |
| Decision Date | 1982-03-02 |