FDA 510(k) Application Details - K123115

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K123115
Device Name	Mask, Surgical
Applicant	ACME FILTER MASK INC. NO. 57 HU SHAN ROAD YINGGE DISTRICT NEW TAIPEI CITY 23941 TW Other 510(k) Applications for this Company
Contact	JEN KE-MIN 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	10/03/2012
Decision Date	05/20/2013
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