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510(k) K213444

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 17, 2022
Date Received
October 25, 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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