Enteric Medical Technologies · Class II · Cleared Apr 13, 2000
| K-number | K000646 |
| Device name | DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE |
| Applicant | Enteric Medical Technologies |
| Product code | FBK |
| Device class | Class II |
| Decision date | Apr 13, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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