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) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-07 |
Decision Date | 2020-01-15 |