FDA 510(k) Application Details - K182480

Device Classification Name	More FDA Info for this Device
510(K) Number	K182480
Device Name	Earlens Contact Hearing Aid
Applicant	Earlens Corporation 4045 Campbell Avenue Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Judith A. Brimacombe 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	09/10/2018
Decision Date	01/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review