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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, implanted
510(k) Number K022905
Device Name LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Applicant Contact SCOTT MOELLER
Correspondent
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Correspondent Contact SCOTT MOELLER
Regulation Number876.5540
Classification Product Code
MSD  
Date Received09/03/2002
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
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