FDA 510(k) Application Details - K223122

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K223122
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	S.B.M. SAS (Science & Bio Materials) ZI du Monge Lourdes 65100 FR Other 510(k) Applications for this Company
Contact	Anne Cospin-Latapie 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	10/03/2022
Decision Date	08/03/2023
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
Expedited Review