FDA 510(k) Application Details - K122735

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K122735
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	SORIN GROUP USA INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	SCOTT LIGHT 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	09/06/2012
Decision Date	05/21/2013
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