FDA 510(k) Application Details - K210215

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K210215
Device Name	Gown, Surgical
Applicant	Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town Changzhou 213251 CN Other 510(k) Applications for this Company
Contact	Tang Hongfang 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	01/27/2021
Decision Date	07/07/2021
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