FDA 510(k) Application Details - K152538

Device Classification Name	Retractor   More FDA Info for this Device
510(K) Number	K152538
Device Name	Retractor
Applicant	J.R. PARKER, LLC 1665 WARPATH ROAD WEST CHESTER, PA 19382 US Other 510(k) Applications for this Company
Contact	J RICHARD PARKER Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2015
Decision Date	04/13/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review