FDA.report

510(k) K140160

Device
RELIEVA SCOUT SINUS DILATION SYSTEM
Applicant
ACCLARENT, INC.
510(k) number
K140160
Product code
LRC  
Decision
Substantially Equivalent (SESE)
Decision date
2014-02-20
Date received
2014-01-22
Regulation
874.4420
Classification name
Instrument, Ent Manual Surgical
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JAMES P GARVEY, II
Address
1525-B O'Brien Dr. Rmenlo Park CA US 94025 94025

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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