FDA 510(k) Application Details - K203821

Device Classification Name	More FDA Info for this Device
510(K) Number	K203821
Device Name	Donagamex Blue Performance Protective Gown
Applicant	Dong Nai Garment Corporation (Donagamex) Road 2, Bien Hoa Industrial Zone 1 An Binh Ward Bien Hoa City 810000 VN Other 510(k) Applications for this Company
Contact	Bui The Kich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2020
Decision Date	12/17/2021
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