FDA 510(k) Application Details - K032008

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

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510(K) Number K032008
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact JODI LYNN GREENIZEN
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 06/30/2003
Decision Date 07/14/2003
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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