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FDA 510(k) Application Details - K994068
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K994068
Device Name
Catheter, Biliary, Diagnostic
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact
ELENA JUGO
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
12/02/1999
Decision Date
12/23/1999
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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