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510(k) K160877

United Urologics Closed System Catheter by Robling Medical, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
March 30, 2016
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

Other clearances by Robling Medical, Inc.

  • K160795 — United Urologics Intermittent Catheter (June 16, 2016)

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