The following data is part of a premarket notification filed by Deka Research & Development with the FDA for Unity Subcutaneous Delivery System For Remodulin.
| Device ID | K190182 |
| 510k Number | K190182 |
| Device Name: | Unity Subcutaneous Delivery System For Remodulin |
| Classification | Pump, Infusion |
| Applicant | DEKA Research & Development 340 Commercial Street Manchester, NH 03101 |
| Contact | Brian Carney |
| Correspondent | Brian Carney DEKA Research & Development 340 Commercial Street Manchester, NH 03101 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-05-06 |