The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set.
| Device ID | K162812 |
| 510k Number | K162812 |
| Device Name: | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3 Osted, DK Dk-4000 |
| Contact | John M. Lindskog |
| Correspondent | Lee Leichter P/L BIOMEDICAL 10882 STONINGTON AVENUE Fort Myers, FL 33913 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-06 |
| Decision Date | 2017-11-01 |
| Summary: | summary |