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FDA 510(k) Application Details - K071646
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K071646
Device Name
Catheter, Biliary, Diagnostic
Applicant
IDEV TECHNOLOGIES, INC.
1120 NASA PKWY., SUITE 600
HOUSTON, TX 77058 US
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Contact
TIMOTHY R PLACEK
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
06/18/2007
Decision Date
01/31/2008
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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