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510(k) K182511

SimplCath by F&S Medical Solutions, LLC — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2019
Date Received
September 12, 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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