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FDA 510(k) Application Details - K090559
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K090559
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO, TX 78215 US
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Contact
CLYDE BAKER
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2009
Decision Date
05/04/2009
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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