| K-number | K955019 |
| Device name | UROTRACT I |
| Applicant | Dornier Medtech America, Inc. |
| Product code | KQS |
| Device class | Class I |
| Decision date | Dec 6, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 876.4890 |
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