The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ear And Nose Specula.
| Device ID | K791123 |
| 510k Number | K791123 |
| Device Name: | EAR AND NOSE SPECULA |
| Classification | Speculum, Ent |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | EPY |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-15 |
| Decision Date | 1979-07-10 |