The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys¿ Ez Plus Negative Pressure Wound Therapy Device.
| Device ID | K151326 |
| 510k Number | K151326 |
| Device Name: | RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-07-16 |
| Summary: | summary |