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510(k) K173734

RocaJJ Soft Stents by Promepla Sam — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2018
Date Received
December 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

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