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FDA 510(k) Applications Submitted by CONVATEC LIMITED
FDA 510(k) Number
Submission Date
Device Name
Applicant
K152926
10/05/2015
AQUACEL Ag Surgical SP Dressing
CONVATEC LIMITED
K181206
05/07/2018
GentleCath Glide Intermittent Urinary Catheter
ConvaTec Limited
K161344
05/13/2016
GentleCath Glide Intermittent Catheter
CONVATEC LIMITED
K172924
09/25/2017
GentleCath Intermittent Urinary Catheter
ConvaTec Limited
K180205
01/24/2018
AVELLE Negative Pressure Wound Therapy System
ConvaTec Limited
K173675
11/30/2017
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
ConvaTec Limited
K190114
01/24/2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
ConvaTec Limited
K213283
10/01/2021
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
ConvaTec Limited
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