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GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232665
510(k) Type
Traditional
Applicant
ConvaTec
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/25/2024
Days to Decision
147 days
Submission Type
Summary

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232665
510(k) Type
Traditional
Applicant
ConvaTec
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/25/2024
Days to Decision
147 days
Submission Type
Summary