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FDA 510(k) Application Details - K183051
Device Classification Name
Catheter, Nephrostomy
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510(K) Number
K183051
Device Name
Catheter, Nephrostomy
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Yan Li
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Regulation Number
000.0000
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Classification Product Code
LJE
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More FDA Info for this Product Code
Date Received
11/02/2018
Decision Date
07/16/2019
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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