FDA 510(k) Application Details - K121812

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K121812
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	UltraSonix Medical Corporation 57 Lazy Brook Rd. Monroe, CT 06468 US Other 510(k) Applications for this Company
Contact	RAYMOND KELLY Other 510(k) Applications for this Contact
Regulation Number	868.5150   More FDA Info for this Regulation Number
Classification Product Code	BSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2012
Decision Date	12/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review