FDA 510(k) Application Details - K102548

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K102548
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant FOOTPRINT MEDICAL INC.
1203 CAMDEN STREET
SAN ANTONIO, TX 78215 US
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Contact CLYDE N BAKER
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 09/03/2010
Decision Date 11/26/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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