FDA 510(k) Application Details - K062843

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K062843
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT LABORATORIES
400 Saginaw Drive
Redwood City, CA 94063 US
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Contact KATHRYN MARCHEL
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 09/22/2006
Decision Date 10/17/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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