K122391 is an FDA 510(k) clearance for the MEDTRONIC XOMED, INC.. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 10, 2013, 156 days after receiving the submission on August 7, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K122391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2012 |
| Decision Date | January 10, 2013 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |