The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Medtronic Xomed, Inc..
| Device ID | K122391 |
| 510k Number | K122391 |
| Device Name: | MEDTRONIC XOMED, INC. |
| Classification | Device, Anti-snoring |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Douglas Johnson |
| Correspondent | Douglas Johnson MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-07 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169523272 | K122391 | 000 |
| 00643169523265 | K122391 | 000 |
| 00763000089757 | K122391 | 000 |