FDA 510(k) Application Details - K161629

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K161629
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
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	878.4493   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	06/13/2016
Decision Date	02/10/2017
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