The following data is part of a premarket notification filed by Smith & Nephew Medical Ltd with the FDA for Pico Single Use Negative Pressure Wound Therapy System.
| Device ID | K151436 |
| 510k Number | K151436 |
| Device Name: | PICO Single Use Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW MEDICAL LTD 101 HESSLE ROAD Hull, GB Hu3 2bn |
| Contact | Samantha Neilson |
| Correspondent | Samantha Neilson SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St Petersburg, FL 33716 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-28 |
| Decision Date | 2016-01-28 |
| Summary: | summary |