FDA 510(k) Application Details - K211570

Device Classification Name	More FDA Info for this Device
510(K) Number	K211570
Device Name	Zeolite Hemostatic Gauze
Applicant	Hangzhou Zeo-Innov Life Technology Co., Ltd. R101, Building 2, No.291 Fucheng Road, HEDA Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Lijuan Zhao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2021
Decision Date	02/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review