FDA 510(k) Application Details - K992863

Device Classification Name Stylet, Catheter

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510(K) Number K992863
Device Name Stylet, Catheter
Applicant GUIDANT CORP.
4100 HAMLINE AVE., NORTH
ST. PAUL, MN 55112-5798 US
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Contact SHERYL POGANSKI
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Regulation Number 870.1380

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Classification Product Code DRB
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Date Received 08/25/1999
Decision Date 11/12/1999
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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