| K-number | K923136 |
| Device name | MALE EXTERNAL CATHETER |
| Applicant | Rochester Medical Corp. |
| Product code | EXJ |
| Device class | Class I |
| Decision date | Dec 3, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 876.5250 |
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