FDA 510(k) Application Details - DEN100025

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100025
Device Name	WIDEXLINK IN CLEAR SERIES HEARING AIDS
Applicant	OFFICE RESEARCH IN CLINICAL AMPLIFICTION 2300 CABOT DRIVE SUITE 415 LISLE, IL 60532 US Other 510(k) Applications for this Company
Contact	FRANCIS KUK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2010
Decision Date	03/31/2011
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review