| K-number | K200142 |
| Device name | SpeediCath Soft |
| Applicant | Coloplast |
| Product code | GBM |
| Device class | Class II |
| Decision date | Jul 30, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov