The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Renasys-f Xl Foam Dressing Kit With Soft Port, Renasys Xl Transparent Film Dressing.
| Device ID | K202783 |
| 510k Number | K202783 |
| Device Name: | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Steeve Lamvohee |
| Correspondent | Steeve Lamvohee Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223500207 | K202783 | 000 |
| 05000223500184 | K202783 | 000 |