FDA 510(k) Application Details - K163279

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K163279
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Medtronic Sofamor Danek, USA, Inc. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Julie Bassett 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	11/21/2016
Decision Date	02/23/2017
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