FDA 510(k) Application Details - K161633

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyamide   More FDA Info for this Device
510(K) Number	K161633
Device Name	Suture, Nonabsorbable, Synthetic, Polyamide
Applicant	SM ENG CO., LTD 46, NAKDONG-DAERO 1302BEON-GIL SASANG-GU KR Other 510(k) Applications for this Company
Contact	SOON-GU LEE Other 510(k) Applications for this Contact
Regulation Number	878.5020   More FDA Info for this Regulation Number
Classification Product Code	GAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2016
Decision Date	03/02/2017
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