FDA 510(k) Application Details - K043500

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K043500
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	INNOSPINE, INC. 11240 MAGDALENA ROAD LOS ALTOS HILLS, CA 94024 US Other 510(k) Applications for this Company
Contact	LARAINE PANGELINA 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	12/20/2004
Decision Date	04/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review