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FDA 510(k) Application Details - K111149
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K111149
Device Name
Catheter, Biliary, Diagnostic
Applicant
M.I. TECH CO., LTD.
1733 CANTON LANE
MARIETTA, GA 30062 US
Other 510(k) Applications for this Company
Contact
PAUL SUMNER
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
FGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2011
Decision Date
12/30/2011
Decision
SESU - SE - WITH LIMITATIONS
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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