FDA.report

510(k) K150453

Device
TULA Iontophoresis System With Earset
Applicant
ACCLARENT, INC.
510(k) number
K150453
Product code
EGJ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-05-20
Date received
2015-02-20
Regulation
890.5525
Classification name
Device, Iontophoresis, Other Uses
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
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
PAVAN SETHI
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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