FDA 510(k) Application Details - K143159

Device Classification Name	More FDA Info for this Device
510(K) Number	K143159
Device Name	Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ╪4.0mm, PediGuard Tri Tip ╪3.2mm, PediGuard Tri Tip ╪2.5mm, PediGuard ╪2.5mm XS, PediGuard Curv, PediGuard Curv
Applicant	SpineGuard, S.A. 5-7 rue de lÆAmiral Courbet Saint Mande 94160 FR Other 510(k) Applications for this Company
Contact	Stephane Bette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2014
Decision Date	01/23/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review