FDA 510(k) Application Details - K001951

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K001951
Device Name	PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
Applicant	PRIMELINE MEDICAL PRODUCTS, INC. 10707 100TH AVE., SUITE 300 EDMONTON, ALBERTA Other 510(k) Applications for this Company   More Company Info and Competitors
Contact	KATHERINE CO 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	06/27/2000
Decision Date	09/08/2000
Decision	SE - Substantially Equivalent
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review	N