FDA 510(k) Application Details - K233068

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K233068
Device Name	Gown, Surgical
Applicant	Nanning TECBOD Biological Technology Co.,Ltd. Room 601 Fool 6, B2 Building, No. 19 Guokai Dadao, Nanning, Guangxi, People's Republic Nanning 530033 CN Other 510(k) Applications for this Company
Contact	Bing Yao Chen 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	09/26/2023
Decision Date	03/29/2024
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