The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Uno Negative Pressure Wound Therapy System.
| Device ID | K180840 |
| 510k Number | K180840 |
| Device Name: | UNO Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville, NY 11801 |
| Contact | Andrew Goh |
| Correspondent | Andrew Goh Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville, NY 11801 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-11-30 |
| Summary: | summary |