FDA 510(k) Application Details - K132043

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K132043
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	ARTHREX, INC. 1370 CREEKSIDE BLVD. NAPLES, FL 34108-1945 US Other 510(k) Applications for this Company
Contact	LEON BROWN II, PH.D. 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	07/02/2013
Decision Date	07/31/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review