FDA 510(k) Application Details - K160564

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K160564
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	GORDIAN SURGICAL LTD. 17TH TCHELET ST. KARMIEL 2161401 IL Other 510(k) Applications for this Company
Contact	ZVI PEER Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/29/2016
Decision Date	11/17/2016
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