FDA 510(k) Application Details - K233571

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K233571
Device Name	Gown, Surgical
Applicant	George Courey Inc 6620, Ernest-Cormier Laval H7C 2T5 CA Other 510(k) Applications for this Company
Contact	Cort Naab 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	11/06/2023
Decision Date	08/02/2024
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