FDA 510(k) Application Details - K974640

Device Classification Name Dilator, Vessel, For Percutaneous Catheterization

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510(K) Number K974640
Device Name Dilator, Vessel, For Percutaneous Catheterization
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact WANDA CARPINELLA
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Regulation Number 870.1310

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Classification Product Code DRE
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Date Received 12/15/1997
Decision Date 03/13/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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