510(k) K173596

Rusch Intermittent Urethral Catheters by Teleflex Medical — Product Code EZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2018
Date Received
November 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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