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 | K161599 |
| 510k Number | K161599 |
| 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 | Chien Ming Goh |
| Correspondent | Chien Ming 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 | 2016-06-09 |
| Decision Date | 2017-04-06 |
| Summary: | summary |