FDA 510(k) Application Details - K190264

Device Classification Name	Suture, Surgical, Absorbable, Polydioxanone   More FDA Info for this Device
510(K) Number	K190264
Device Name	Suture, Surgical, Absorbable, Polydioxanone
Applicant	MEDITIME Co., Ltd #605 Medical Device Complex, 200, Gieupdosi-ro, Jijeong-Myeon Won Ju 90010 KR Other 510(k) Applications for this Company
Contact	Yong Baik Kim 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	02/08/2019
Decision Date	08/15/2019
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