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FDA 510(k) Application Details - K172929
Device Classification Name
Catheter, Nephrostomy
More FDA Info for this Device
510(K) Number
K172929
Device Name
Catheter, Nephrostomy
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact
Daniel FitzDaniel
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LJE
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More FDA Info for this Product Code
Date Received
09/25/2017
Decision Date
01/10/2018
Decision
SESE - SUBST EQUIV
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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