FDA 510(k) Application Details - K162366

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K162366
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	OV WORLD CO., LTD (GASAN-DONG, FORMATEC BD)A-202,213 205-28, GASAN DIGITAL 1-R GEUMCHEON-GU SEOUL KR Other 510(k) Applications for this Company
Contact	GEUNG-GYU GANG Other 510(k) Applications for this Contact
Regulation Number	878.4840   More FDA Info for this Regulation Number
Classification Product Code	NEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2016
Decision Date	03/02/2018
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