FDA 510(k) Application Details - K233183

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K233183
Device Name	Gown, Surgical
Applicant	Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Southern Industrial Zone (Xinlirenkou) Xiantao 433011 CN Other 510(k) Applications for this Company
Contact	Melody Wang 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	09/28/2023
Decision Date	02/01/2024
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