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FDA Product Code

FDA Product Code OSM — Clearance Directory

Device Class
Class II
Assigned Panel
Ear, Nose, Throat
21 CFR Citation
874.3305

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN100025 WIDEXLINK IN CLEAR SERIES HEARING AIDS Office Research IN Clinical Amplifiction 2011-03-31 Post-NSE —

Product code OSM · Class II · Ear, Nose, Throat. Data: openFDA.