FDA 510(k) Application Details - K111402

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K111402
Device Name	Mask, Surgical
Applicant	KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	ANN WATERHOUSE, RAC Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2011
Decision Date	10/20/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review