The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Neria Guard Infusion Set.
| Device ID | K192647 |
| 510k Number | K192647 |
| Device Name: | Neria Guard Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Unomedical A/s Aaholmvej 1-3 Osted, DK Dk-4320 |
| Contact | Mette Busk Henningsen |
| Correspondent | Deirdre Barrow Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 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 | 2019-09-24 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05705244022362 | K192647 | 000 |
| 05705244022003 | K192647 | 000 |
| 05705244022034 | K192647 | 000 |
| 05705244022065 | K192647 | 000 |
| 05705244022096 | K192647 | 000 |
| 05705244022126 | K192647 | 000 |
| 05705244022157 | K192647 | 000 |
| 05705244022188 | K192647 | 000 |
| 05705244022218 | K192647 | 000 |
| 05705244022249 | K192647 | 000 |
| 05705244022270 | K192647 | 000 |
| 05705244022300 | K192647 | 000 |
| 05705244022331 | K192647 | 000 |
| 05705244021976 | K192647 | 000 |