FDA 510(k) Application Details - K171823

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K171823
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	U&U Medical Technology Co., Ltd Dongzhou Village Hengshanqiao Changzhou 213119 CN Other 510(k) Applications for this Company
Contact	Xuebo Wang Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2017
Decision Date	02/22/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review