FDA 510(k) Application Details - K032624

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K032624
Device Name Catheter, Intravascular, Diagnostic
Applicant MICRUS CORP.
610 PALOMAR AVENUE
MOUNTAIN VIEW, CA 94085 US
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Contact MARGARET WEBBER
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Regulation Number 870.1200

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Classification Product Code DQO
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Date Received 08/26/2003
Decision Date 09/10/2003
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 Y
Expedited Review



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