FDA 510(k) Application Details - K153076

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K153076
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Natalie Hichak Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2015
Decision Date	06/16/2016
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