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FDA 510(k) Application Details - K072293
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K072293
Device Name
Stent, Ureteral
Applicant
FOSSA MEDICAL, INC.
50 REDFIELD STREET
BOSTON, MA 02122 US
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Contact
GLORIA KOLB
Other 510(k) Applications for this Contact
Regulation Number
876.4620
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Classification Product Code
FAD
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More FDA Info for this Product Code
Date Received
08/16/2007
Decision Date
08/06/2008
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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