FDA 510(k) Application Details - K192637

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K192637
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Yunyi (Beijing) Medical Device Co., LTD Floor 1-4, Building 4, No. 9 Tianfu Street Biomedical Base, Daxing District Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Xiaowei Liu Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2019
Decision Date	03/02/2020
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