FDA 510(k) Application Details - K190707

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K190707
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 US Other 510(k) Applications for this Company
Contact	David L Rogers 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	03/19/2019
Decision Date	10/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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