The following data is part of a premarket notification filed by Genadyne Biotechnologies with the FDA for Uno 30.
| Device ID | K190028 |
| 510k Number | K190028 |
| Device Name: | UNO 30 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Genadyne Biotechnologies 16 Midland Ave Hicksville, NY 11801 |
| Contact | Andrew Goh |
| Correspondent | Swara Vashi Genadyne Biotechnologies 16 Midland Ave Hicksville, NY 11801 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2020-01-15 |