FDA 510(k) Application Details - K090042

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K090042
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	NEWMARK, INC. 919 EIGHTEENTH STREET NW SUITE 600 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	DEBORAH LIVORNESE Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2009
Decision Date	05/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review