FDA 510(k) Application Details - K153554

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K153554
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	CareFusion 2200 Inc 75 N. Fairway Drive Vernon Hills, IL 60061 US Other 510(k) Applications for this Company
Contact	Jane Weber Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2015
Decision Date	03/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review