FDA.report

510(k) K110623

Device
PILLAR PALATAL IMPLANT SYSTEM
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K110623
Product code
LRK  
Decision
Substantially Equivalent (SESE)
Decision date
2012-02-10
Date received
2011-03-03
Regulation
872.5570
Classification name
Device, Anti-snoring
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROZANNE PACIEJ
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10866369000009PillarPILLAR PALATAL, LLC2016-08-15

Legacy Summary

summary

FDA Review

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