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510(k) K181979

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter by Teleflexmedical, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2019
Date Received
July 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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