FDA 510(k) Application Details - K221354

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K221354
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	Lai Saeteurn 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	05/10/2022
Decision Date	09/09/2022
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
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