| K-number | K130755 |
| Device name | HICUT HIGHSPEED INSTRUMENT |
| Applicant | Adeor Medical AG |
| Product code | HBE |
| Device class | Class II |
| Decision date | Jun 27, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 882.4310 |
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