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510(k) K212868

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT by Rocamed Sam — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2022
Date Received
September 9, 2021
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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