The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Minimed Quick-set® Minimed Sure-t® Minimed Silhouette® Minimed Mio®.
| Device ID | K160648 |
| 510k Number | K160648 |
| Device Name: | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3 Osted, DK 4320 |
| Contact | John M Lindskog |
| Correspondent | Cindie Vandfeldt UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4320 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-08-10 |
| Summary: | summary |