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510(k) K183461

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter by Teleflexmedical, Inc. — Product Code GBM

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 8, 2019
Date Received
December 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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