FDA 510(k) Application Details - K240097

Device Classification Name	More FDA Info for this Device
510(K) Number	K240097
Device Name	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
Applicant	Ushare Medical Inc. #445, Anji Zhong Road,Sanzao Town Zhuhai 519040 CN Other 510(k) Applications for this Company
Contact	Yun Chen 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	01/12/2024
Decision Date	05/22/2024
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