FDA 510(k) Application Details - K051291

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K051291
Device Name	NON-STERILE SURGICAL MASK
Applicant	A.R. MEDICOM, INC. 1200 55TH AVE. LACHINE, QUEBEC Other 510(k) Applications for this Company   More Company Info and Competitors
Contact	LUC TREPANIER 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	05/18/2005
Decision Date	09/20/2005
Decision	SE - Substantially Equivalent
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	N