The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Comfort And Inset Subcutaneous Infusion Sets For Use With Abbott Infusion Pumps.
| Device ID | K051264 |
| 510k Number | K051264 |
| Device Name: | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde, DK 4000 |
| Contact | John Lindskog |
| Correspondent | John Lindskog UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde, DK 4000 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-09-01 |
| Summary: | summary |