The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Minimed Mio Advance Infusion Set.
| Device ID | K173879 |
| 510k Number | K173879 |
| Device Name: | MiniMed Mio Advance Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Unomedical A/S Aaholmvej 1-3 Osted, DK Dk-4320 |
| Contact | Heidi Bjerre Lovkvist |
| Correspondent | Deirdre Barrow Emergo Global Consulting, LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05705244016514 | K173879 | 000 |
| 05705244021853 | K173879 | 000 |
| 05705244021822 | K173879 | 000 |
| 05705244021792 | K173879 | 000 |
| 05705244021761 | K173879 | 000 |
| 05705244021730 | K173879 | 000 |
| 05705244021709 | K173879 | 000 |
| 05705244019096 | K173879 | 000 |
| 05705244019065 | K173879 | 000 |
| 05705244018945 | K173879 | 000 |
| 05705244018914 | K173879 | 000 |
| 05705244018884 | K173879 | 000 |
| 05705244021884 | K173879 | 000 |
| 00570524416156 | K173879 | 000 |
| 05705244016484 | K173879 | 000 |
| 05705244016453 | K173879 | 000 |
| 05705244016422 | K173879 | 000 |
| 05705244016392 | K173879 | 000 |
| 05705244016361 | K173879 | 000 |
| 05705244016330 | K173879 | 000 |
| 05705244016309 | K173879 | 000 |
| 05705244016279 | K173879 | 000 |
| 05705244016248 | K173879 | 000 |
| 05705244016217 | K173879 | 000 |
| 00570524416187 | K173879 | 000 |
| 05705244025189 | K173879 | 000 |