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510(k) K160795

United Urologics Intermittent Catheter by Robling Medical — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2016
Date Received
March 23, 2016
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

Other clearances by Robling Medical

  • K160877 — United Urologics Closed System Catheter (May 20, 2016)

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