FDA 510(k) Application Details - K113340

Device Classification Name	More FDA Info for this Device
510(K) Number	K113340
Device Name	KIMBERLY-CLARK CHILD'S FACEMASK
Applicant	KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	ANN WATERHOUSE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2011
Decision Date	05/04/2012
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