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GentleCath Glide Intermittent Urinary Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181206
510(k) Type
Traditional
Applicant
ConvaTec Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
8/16/2018
Days to Decision
101 days
Submission Type
Summary

GentleCath Glide Intermittent Urinary Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181206
510(k) Type
Traditional
Applicant
ConvaTec Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
8/16/2018
Days to Decision
101 days
Submission Type
Summary