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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K032754
Device Name VORTEX MP
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 Number880.5965
Classification Product Code
LJT  
Date Received09/05/2003
Decision Date 09/12/2003
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
Recalls CDRH Recalls
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