FDA 510(k) Application Details - K151594

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K151594
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Cora Sim 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	06/12/2015
Decision Date	01/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review