The following data is part of a premarket notification filed by Cork Medical Products, Llc with the FDA for Nisus Touch Negative Pressure Wound Therapy Pump.
| Device ID | K203693 |
| 510k Number | K203693 |
| Device Name: | Nisus Touch Negative Pressure Wound Therapy Pump |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Cork Medical Products, LLC 8000 Castleway Drive Indianapolis, IN 46250 |
| Contact | Patrick Mcginley |
| Correspondent | Patrick Mcginley Cork Medical Products, LLC 8000 Castleway Drive Indianapolis, IN 46250 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-08-13 |