FDA 510(k) Application Details - K191174

Device Classification Name	More FDA Info for this Device
510(K) Number	K191174
Device Name	Mercy babyTAPE
Applicant	Children's Mercy Hospital 2401 Gilham Road 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	05/01/2019
Decision Date	10/10/2019
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