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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K031718
Device Name LIFEVALVE CENTRAL VENOUS CATHTER
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 Number880.5970
Classification Product Code
LJS  
Date Received06/03/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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