FDA 510(k) Application Details - K111767

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K111767
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 19 HA'HAROSHET ST. RA'ANANA 43654 IL Other 510(k) Applications for this Company
Contact	MONICA STACHURA,JD Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2011
Decision Date	09/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review