FDA 510(k) Application Details - K033473

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

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510(K) Number K033473
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER, GA 31816 US
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Contact SCOTT MOELLER
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 11/03/2003
Decision Date 11/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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