Submission Details
| 510(k) Number | K110623 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2011 |
| Decision Date | February 10, 2012 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
PILLAR PALATAL IMPLANT SYSTEM
Feb 2012
Decision
344d
Days
Class 2
Risk
About This 510(k) Submission
K110623 is an FDA 510(k) clearance for the PILLAR PALATAL IMPLANT SYSTEM, 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 February 10, 2012, 344 days after receiving the submission on March 3, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.
Device Classification
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
Manufacturer
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