PRIMAGARD SURGICAL EQUIPMENT DRAPES


Device Classification Name

drape, surgical

510(k) Number K022868
Device Name PRIMAGARD SURGICAL EQUIPMENT DRAPES
Original Applicant
PRIMELINE MEDICAL PRODUCTS, INC.
10707-100th ave., suite 300
edmonton, alberta, 

CA

t5j 3m1

Original Contact brenda lee
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 08/29/2002
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