FDA 510(k) Application Details - K171494

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K171494
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	Gordian Surgical Ltd. 17 Tchelet Street Misgav Business Park 2017400 IL Other 510(k) Applications for this Company
Contact	Amir Schvartzer 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	05/22/2017
Decision Date	06/15/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review