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FDA 510(k) Application Details - K152069
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K152069
Device Name
Catheter, Biliary, Diagnostic
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH, MA 01752 US
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Contact
MICHAEL P. HANLEY
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
07/27/2015
Decision Date
09/24/2015
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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