FDA 510(k) Application Details - K161758

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K161758
Device Name	Clip, Implantable
Applicant	TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	HOLLY HALLOCK Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2016
Decision Date	09/07/2016
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