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FDA 510(k) Application Details - K955126
Device Classification Name
Catheter, Biliary, Diagnostic
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510(K) Number
K955126
Device Name
Catheter, Biliary, Diagnostic
Applicant
LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM, CA 92806 US
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Contact
DANIEL R LUCAS
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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
11/09/1995
Decision Date
05/10/1996
Decision
SESE - SUBST EQUIV
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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