The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Unomedical Monica Infusion Set.
| Device ID | K032854 |
| 510k Number | K032854 |
| Device Name: | UNOMEDICAL MONICA INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
| Contact | John M Lindskog |
| Correspondent | John M Lindskog UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-12 |
| Decision Date | 2003-10-09 |
| Summary: | summary |