The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys; Ez Max Negative Pressure Wound Therapy; Foam Npwt Wound Dressing Kits With Soft Port; Gauze Npwt Wound Dressing Kits With Soft Port; Ez Plus/ez Max Canisters.
| Device ID | K142979 |
| 510k Number | K142979 |
| Device Name: | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits With Soft Port; Gauze NPWT Wound Dressing Kits With Soft Port; EZ PLUS/EZ MAX Canisters |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE110 St. Petersburg, FL 33716 |
| Contact | Laurea Reynolds |
| Correspondent | Laurea Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE110 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 | 2014-10-15 |
| Decision Date | 2015-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565123943 | K142979 | 000 |
| 30040565127249 | K142979 | 000 |
| 05000223491499 | K142979 | 000 |
| 30040565125672 | K142979 | 000 |
| 30040565127263 | K142979 | 000 |
| 30040565127270 | K142979 | 000 |
| 30040565127126 | K142979 | 000 |
| 00040565127132 | K142979 | 000 |
| 00040565125565 | K142979 | 000 |
| 00040565126470 | K142979 | 000 |
| 00040565127286 | K142979 | 000 |
| 00040565127309 | K142979 | 000 |
| 30040565124224 | K142979 | 000 |
| 30040565127164 | K142979 | 000 |
| 30040565127171 | K142979 | 000 |
| 30040565127188 | K142979 | 000 |
| 00040565125909 | K142979 | 000 |
| 30040565127232 | K142979 | 000 |
| 30040565125689 | K142979 | 000 |