The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Transsphenoidal Handpiece.
| Device ID | K781418 |
| 510k Number | K781418 |
| Device Name: | XOMED TRANSSPHENOIDAL HANDPIECE |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-16 |
| Decision Date | 1978-08-31 |