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FDA 510(k) Application Details - K170898
Device Classification Name
Dislodger, Stone, Biliary
More FDA Info for this Device
510(K) Number
K170898
Device Name
Dislodger, Stone, Biliary
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402 US
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Contact
Erum B. Nasir
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
LQR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/2017
Decision Date
12/12/2017
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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