FDA 510(k) Application Details - K142469

Device Classification Name	More FDA Info for this Device
510(K) Number	K142469
Device Name	2D Mercy TAPE & 3D Mercy TAPE
Applicant	Children's Mercy Hospital 2401 Gilham Road, Suite 0411 Kansas City, MO 64108 US Other 510(k) Applications for this Company
Contact	Susan Abdel-Rahman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2014
Decision Date	05/01/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review