FDA 510(k) Application Details - K081633

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K081633
Device Name	Mask, Surgical
Applicant	PRIMED MEDICAL PRODUCTS INC. SUITE 900, 10707-100 AVE. EDMONTON, ALBERTA T5J 3M1 CA Other 510(k) Applications for this Company
Contact	RAYMOND G MARUSYK 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	06/11/2008
Decision Date	08/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review