FDA 510(k) Application Details - K212698

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K212698
Device Name	Gown, Isolation, Surgical
Applicant	Foshan Nanhai Plus Medical Co Ltd Shatou Jiujiang Town, Nanhai District Foshan 528208 CN Other 510(k) Applications for this Company
Contact	Eric Li Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2021
Decision Date	03/02/2022
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