FDA 510(k) Application Details - K060846

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K060846
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	ENDURANCE THERAPEUTICS 122B - FIRST STREET NE DAUPHIN, MANITOBA R7N 1B5 CA Other 510(k) Applications for this Company
Contact	BRAD BREZDEN 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	03/28/2006
Decision Date	12/03/2007
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