FDA 510(k) Application Details - K192560

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K192560
Device Name	Gown, Surgical
Applicant	Shandong Kangli Medical Equipment Technology Co., Ltd. Huiquan East Road, Shizhong District Zaozhuang 277117 CN Other 510(k) Applications for this Company
Contact	Zhuang Liu Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2019
Decision Date	05/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review