FDA 510(k) Application Details - K041762

Device Classification Name Wire, Guide, Catheter

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510(K) Number K041762
Device Name Wire, Guide, Catheter
Applicant GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL, MN 55112-5498 US
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Contact JENNIFER TANG
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 06/30/2004
Decision Date 08/06/2004
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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