FDA 510(k) Application Details - K233526

Device Classification Name	More FDA Info for this Device
510(K) Number	K233526
Device Name	Medline Open-back Level 3 Protective Gown
Applicant	Medline Industries, LP 1 Three Lakes Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Kelsey Closen 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	11/01/2023
Decision Date	03/05/2024
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