FDA 510(k) Application Details - K142768

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K142768
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	SUMMIT MEDICAL, INC. 815 NORTHWEST PARKWAY, SUITE 100 ST. PAUL, MN 55121 US Other 510(k) Applications for this Company
Contact	NICOLE DOVE 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	09/25/2014
Decision Date	05/29/2015
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