Unomedical A/S · Class II · Cleared Nov 1, 2017
| K-number | K162812 |
| Device name | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set |
| Applicant | Unomedical A/S |
| Product code | FPA |
| Device class | Class II |
| Decision date | Nov 1, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 880.5440 |
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