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510(k) K161344

GentleCath Glide Intermittent Catheter by Convatec Limited — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
May 13, 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

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