FDA 510(k) Application Details - K173110

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K173110
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	Summit Medical Ltd. Bourton Industrial Park Bourton on the Water gl54 2hq GB Other 510(k) Applications for this Company
Contact	Robyn Cochrane 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	09/29/2017
Decision Date	05/18/2018
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