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510(k) K192183

RocaTub Ureteral Catheter by Promepal Sam — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2020
Date Received
August 12, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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