The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Goode Magnetic Nasal Splint.
| Device ID | K810738 |
| 510k Number | K810738 |
| Device Name: | GOODE MAGNETIC NASAL SPLINT |
| Classification | Splint, Nasal |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | EPP |
| CFR Regulation Number | 874.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-18 |
| Decision Date | 1981-03-31 |