PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)


Device Classification Name

drape, surgical

510(k) Number K021864
Device Name PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
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 06/06/2002
Decision Date 09/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No