FDA 510(k) Application Details - K212810

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K212810
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	Samyang Holdings Corp., Ltd. 55, Munpyeongseo-ro, 18beon-gil Daedeok-gu 34302 KR Other 510(k) Applications for this Company
Contact	Ahram Kim 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	09/03/2021
Decision Date	08/05/2022
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