FDA 510(k) Application Details - K091018

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyester   More FDA Info for this Device
510(K) Number	K091018
Device Name	Suture, Nonabsorbable, Synthetic, Polyester
Applicant	ARTHREX, INC. 1370 CREEKSIDE BLVD. NAPLES, FL 34108-1945 US Other 510(k) Applications for this Company
Contact	SALLY FOUST Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2009
Decision Date	07/30/2010
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