FDA 510(k) Application Details - DEN210049

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210049
Device Name	Medline ART Skin Harvesting System
Applicant	Medline Industries, Inc Three Lakes Drive Northfield, IL 60093 US Other 510(k) Applications for this Company
Contact	Stephanie Augsburg Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2021
Decision Date	03/27/2024
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review