FDA 510(k) Application Details - K230384

Device Classification Name	More FDA Info for this Device
510(K) Number	K230384
Device Name	PolyWear« Personal Protective Level 3 Gown
Applicant	Polyconversions, INC 3202 Apollo Drive Champaign, IL 61822 US Other 510(k) Applications for this Company
Contact	William Smith 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	02/14/2023
Decision Date	08/11/2023
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