The following data is part of a premarket notification filed by Neogen Technologies, Inc with the FDA for Neogen One, Closed Wound Drain System, Part Number: Ng9900.
| Device ID | K032301 |
| 510k Number | K032301 |
| Device Name: | NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | NEOGEN TECHNOLOGIES, INC 5353 NW 35TH AVE. Ft Lauderdale, FL 33309 |
| Contact | Lydia B Biggie |
| Correspondent | Lydia B Biggie NEOGEN TECHNOLOGIES, INC 5353 NW 35TH AVE. Ft Lauderdale, FL 33309 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-25 |
| Decision Date | 2003-08-21 |