FDA 510(k) Application Details - K093026

Device Classification Name Introducer, Catheter

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510(K) Number K093026
Device Name Introducer, Catheter
Applicant FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO, TX 78215 US
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Contact CLYDE BAKER
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 09/29/2009
Decision Date 02/24/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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