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FDA 510(k) Application Details - K163068
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K163068
Device Name
Stent, Ureteral
Applicant
Q UROLOGICAL CORPORATION
15 KEARNCY ROAD
NEEDHAM, MA 02492 US
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Contact
SCOTT EPSTEIN
Other 510(k) Applications for this Contact
Regulation Number
876.4620
More FDA Info for this Regulation Number
Classification Product Code
FAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2016
Decision Date
12/22/2016
Decision
SESE - SUBST EQUIV
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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