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FDA 510(k) Application Details - K100366
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K100366
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
MAXTER CATHETERS
VILLAGE D'ENTREPRISES
SAINT HENRI II, RUE ANNE GACON
MARSEILLE 13016 FR
Other 510(k) Applications for this Company
Contact
M. BERNARD DAURELLE
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
02/12/2010
Decision Date
06/14/2010
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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