Last synced on 19 July 2024 at 11:05 pm

Self-Cath and Self-Cath Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221401
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2022
Days to Decision
200 days
Submission Type
Summary

Self-Cath and Self-Cath Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221401
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2022
Days to Decision
200 days
Submission Type
Summary