FDA 510(k) Application Details - K142553

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K142553
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	UNISIS CORP. 2675-1, NISHIKATA KOSHIGAYA-SHI 3430822 JP Other 510(k) Applications for this Company
Contact	Tadashi Yasuda 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	09/10/2014
Decision Date	01/14/2015
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