Ellman International, Inc. · Class II · Cleared Jul 12, 2013
| K-number | K123366 |
| Device name | SURGITRON 4.0 DUAL RF S5-IEC |
| Applicant | Ellman International, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Jul 12, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
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