FDA 510(k) Application Details - K152769

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K152769
Device Name	Stimulator, Nerve
Applicant	AD-TECH MEDICAL INSTRUMENT CORPORATION 1901 WILLIAM STREET RACINE, WI 53404 US Other 510(k) Applications for this Company
Contact	LISA THEAMA Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2015
Decision Date	05/06/2016
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