The following data is part of a premarket notification filed by Unomedical A/s Infusion Devices with the FDA for Asante Conset And Asante Comfort Subcutaneous Infusion Sets For Use With Asante Pearl Infusion Pumps.
| Device ID | K120872 |
| 510k Number | K120872 |
| Device Name: | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre, DK Dk-4320 |
| Contact | John M Lindskog |
| Correspondent | John M Lindskog UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre, DK Dk-4320 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-04-20 |
| Summary: | summary |