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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 K010189
Device Name VORTEX ACCESS SYSTEM
Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Applicant Contact PENNY M NORTHCUTT
Correspondent
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER,  GA  31816
Correspondent Contact PENNY M NORTHCUTT
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/22/2001
Decision Date 02/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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