FDA 510(k) Application Details - K062554

Device Classification Name Dilator, Vessel, For Percutaneous Catheterization

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510(K) Number K062554
Device Name Dilator, Vessel, For Percutaneous Catheterization
Applicant ABBOTT VASCULAR INC.
400 SAGINAW DR.
REDWOOD CITY, CA 94063 US
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Contact Daun Putnam
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Regulation Number 870.1310

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Classification Product Code DRE
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Date Received 08/30/2006
Decision Date 02/06/2007
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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