PRIMAGARD SURGICAL GOWNS


Device Classification Name

drape, surgical

510(k) Number K023117
Device Name PRIMAGARD SURGICAL GOWNS
Original Applicant
PRIMELINE MEDICAL PRODUCTS, INC.
10707 100th ave., suite 300
edmonton, alberta, 

CA

t5j 3m1

Original Contact branda lee
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 09/11/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No