FDA 510(k) Application Details - K162247

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K162247
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 LE LOCLE NEUCHATEL 2400 CH Other 510(k) Applications for this Company
Contact	TATYANA KORSUNSKY 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	08/10/2016
Decision Date	12/15/2016
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