FDA 510(k) Application Details - K150771

Device Classification Name	More FDA Info for this Device
510(K) Number	K150771
Device Name	RxG Distraction System
Applicant	KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PKWY. SOUTH JACKSONVILLE, FL 32246 US Other 510(k) Applications for this Company
Contact	JENNIFER DAMATO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2015
Decision Date	08/27/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review