FDA 510(k) Application Details - K192671

Device Classification Name	More FDA Info for this Device
510(K) Number	K192671
Device Name	Hemostatic Xerogel Sponge
Applicant	Solaplus Biotech Co., Ltd. No. 75 Feng Fang Road, Ouhai Economic Development Zone Wenzhou 325014 CN Other 510(k) Applications for this Company
Contact	Xiangui Shen 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	09/26/2019
Decision Date	08/28/2020
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