FDA 510(k) Application Details - K132472

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K132472
Device Name	Staple, Implantable
Applicant	JUSTRIGHT SURGICAL, LLC 128 Blye HIll Landing Newbury, NH 03255 US Other 510(k) Applications for this Company
Contact	MICHELE LUCEY Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2013
Decision Date	02/11/2014
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