LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K022905
Device Name LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
Original Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 horizon way
manchester, 
GA 
31816

Original Contact scott moeller
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 09/03/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No