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FDA 510(k) Application Details - K041370
Device Classification Name
Catheter, Biliary, Diagnostic
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510(K) Number
K041370
Device Name
Catheter, Biliary, Diagnostic
Applicant
ORBUS MEDICAL TECHNOLOGIES
5363 N.W. 35TH AVE.
FT. LAUDERDALE, FL 33309 US
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Contact
JIM CLOSSICK
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
05/24/2004
Decision Date
06/24/2004
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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