The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Neria Soft 90 Infusion Set.
| Device ID | K132142 |
| 510k Number | K132142 |
| Device Name: | NERIA SOFT 90 INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S UNIT B9, TAYLORS COURT, PARKGATE Rotherham, South Yorkshire, GB S62 6nu |
| Contact | Deirdre Barrow |
| Correspondent | Deirdre Barrow UNOMEDICAL A/S UNIT B9, TAYLORS COURT, PARKGATE Rotherham, South Yorkshire, GB S62 6nu |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2013-10-08 |
| Summary: | summary |