FDA 510(k) Application Details - K090576

Device Classification Name Catheter, Straight

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510(K) Number K090576
Device Name Catheter, Straight
Applicant FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO, TX 78215 US
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Contact CLYDE BAKER
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Regulation Number 876.5130

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Classification Product Code EZD
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Date Received 03/03/2009
Decision Date 08/12/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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