FDA 510(k) Application Details - K091488

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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510(K) Number K091488
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO, TX 78215 US
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Contact CLYDE BAKER
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 05/19/2009
Decision Date 09/14/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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