The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne Uno Plus (uno+) Negative Pressure Wound Therapy System.
| Device ID | K210107 |
| 510k Number | K210107 |
| Device Name: | Genadyne UNO Plus (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 | Saiken Ho |
| Correspondent | Saiken Ho 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 | 2021-01-15 |
| Decision Date | 2022-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849405000495 | K210107 | 000 |
| 00849405000488 | K210107 | 000 |
| 00849405000389 | K210107 | 000 |