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FDA 510(k) Application Details - K073667
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K073667
Device Name
Catheter, Biliary, Diagnostic
Applicant
TAEWOONG MEDICAL CO., LTD
5536 TROWBRIDGE DRIVE
DUNWOODY, GA 30338 US
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Contact
CATHRYN N CAMBRIA
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
12/26/2007
Decision Date
11/19/2008
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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