FDA 510(k) Application Details - K220665

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K220665
Device Name	Gown, Surgical
Applicant	Excellent Medical Technology Group Co., Ltd. Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road Suzhou 215131 CN Other 510(k) Applications for this Company
Contact	Kenney Song 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	03/07/2022
Decision Date	06/03/2022
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