FDA 510(k) Application Details - K141875

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K141875
Device Name	Mask, Surgical
Applicant	PASTURE PHARMA PTE LTD 38129 SPRING CANYON DRIVE MURRIETA, CA 92563 US Other 510(k) Applications for this Company
Contact	SARAH HASSAN 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	07/11/2014
Decision Date	05/05/2015
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