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510(k) K232920

RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm by Ureteral Stent Company — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
September 19, 2023
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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