FDA 510(k) Application Details - K023507

Device Classification Name Dilator, Vessel, For Percutaneous Catheterization

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510(K) Number K023507
Device Name Dilator, Vessel, For Percutaneous Catheterization
Applicant VASCUMETRIX, LLC
2824 NORTH POWER RD., #113-278
MESA, AZ 85215-1674 US
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Contact NICK RAIBLE
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Regulation Number 870.1310

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Classification Product Code DRE
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Date Received 10/18/2002
Decision Date 11/08/2002
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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