FDA 510(k) Application Details - K100992

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K100992
Device Name	Stimulator, Nerve
Applicant	INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") 55 NORTHERN BLVD SUITE 200 GREAT NECK, NY 10021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	04/09/2010
Decision Date	09/24/2010
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