FDA 510(k) Application Details - K202844

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K202844
Device Name	Gown, Surgical
Applicant	Beijing Biosis Healing Biological Technology Co., Ltd No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Ting Jiang 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	09/25/2020
Decision Date	01/06/2021
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