Last synced on 14 June 2024 at 11:05 pm

Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luj

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230165
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2023
Days to Decision
217 days
Submission Type
Summary

Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luj

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230165
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2023
Days to Decision
217 days
Submission Type
Summary