FDA 510(k) Application Details - K033742

Device Classification Name Wire, Guide, Catheter

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510(K) Number K033742
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact DEBORAH THOMAS
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/28/2003
Decision Date 01/12/2004
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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