| K-number | K090055 |
| Device name | LOW & HIGH SPEED KIT |
| Applicant | Dpm USA Corp. |
| Product code | EFA |
| Device class | Class I |
| Decision date | Oct 27, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 872.4200 |
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