FDA 510(k) Application Details - K142416

Device Classification Name	More FDA Info for this Device
510(K) Number	K142416
Device Name	Luma Wrap
Applicant	Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 US Other 510(k) Applications for this Company
Contact	Aurelia Browndridge Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2014
Decision Date	06/12/2015
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