FDA 510(k) Application Details - K180191

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K180191
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Arcuro Medical Ltd. 17 Tchelet St. Misgav 2017400 IL Other 510(k) Applications for this Company
Contact	Lee Ranon 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	01/23/2018
Decision Date	06/05/2018
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