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FDA 510(k) Application Details - K181971
Device Classification Name
Stent, Ureteral
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510(K) Number
K181971
Device Name
Stent, Ureteral
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Paul Meyer
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Regulation Number
876.4620
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Classification Product Code
FAD
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Date Received
07/24/2018
Decision Date
04/23/2019
Decision
SESK - SUBST EQUIV - KIT
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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