FDA 510(k) Application Details - K212258

Device Classification Name	General Surgery Tray   More FDA Info for this Device
510(K) Number	K212258
Device Name	General Surgery Tray
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	878.4370   More FDA Info for this Regulation Number
Classification Product Code	LRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2021
Decision Date	12/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review