FDA 510(k) Application Details - K955587

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

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510(K) Number K955587
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact WANDA M CARPINELLA
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 12/07/1995
Decision Date 03/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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