Coloplast · Class II · Cleared Aug 25, 2023
| K-number | K230165 |
| Device name | 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), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) |
| Applicant | Coloplast |
| Product code | EZD |
| Device class | Class II |
| Decision date | Aug 25, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
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