FDA 510(k) Application Details - K222189

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K222189
Device Name	Dressing, Wound, Drug
Applicant	SiOxMed, LLC. 2011 Muddy Creek Road Clemmons, NC 27012 US Other 510(k) Applications for this Company
Contact	Mitch Dellinger Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2022
Decision Date	11/18/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review