FDA 510(k) Application Details - K182656

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K182656
Device Name	Wrap, Sterilization
Applicant	Jiangsu Zhande Medical Supplies Co., Ltd Nanjing Binjiang Economic Development Park #719 Shengan Avenue, 1/F Build. Nanjing 211178 CN Other 510(k) Applications for this Company
Contact	Chanjuan Xu Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2018
Decision Date	06/11/2019
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