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510(k) K191187

Dornier MINNOW Ureteral Catheter by Dornier Medtech America, Inc. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2019
Date Received
May 3, 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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  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
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