FDA 510(k) Application Details - DEN150002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150002
Device Name	EarLens Contact Hearing Device
Applicant	EARLENS CORPORATION 4045-A CAMBBELL AVENUE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	SUZANNE LEVY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2015
Decision Date	09/29/2015
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review