The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys Go Negative Pressure Wound Therapy.
| Device ID | K083375 |
| 510k Number | K083375 |
| Device Name: | RENASYS GO NEGATIVE PRESSURE WOUND THERAPY |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716 |
| Contact | Laura Krejci |
| Correspondent | Laura Krejci SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. 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 | 2008-11-14 |
| Decision Date | 2009-02-25 |
| Summary: | summary |