FDA 510(k) Application Details - K213893

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K213893
Device Name	Gown, Surgical
Applicant	Xuchang Zhengde Environstar Medical Products Co., Ltd. Area B, Baihua Road East, South Side of Erji river, Industry Cluster District, Yanling County Xuchang 461200 CN Other 510(k) Applications for this Company
Contact	Vincent Yu 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	12/14/2021
Decision Date	12/21/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review