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510(k) K181206

GentleCath Glide Intermittent Urinary Catheter by Convatec Limited — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2018
Date Received
May 7, 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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