PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM


Device Classification Name

mask, surgical

510(k) Number K021076
Device Name PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
Original Applicant
PRIMELINE MEDICAL PRODUCTS, INC.
10707-100th ave., suite 300
edmonton, alberta, 

CA

t5j 3m1

Original Contact brenda lee
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 04/03/2002
Decision Date 04/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No