The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Renasys Touch; Renasys Y-connector.
| Device ID | K181822 |
| 510k Number | K181822 |
| Device Name: | RENASYS Touch; RENASYS Y-Connector |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Lavinia Tompkins |
| Correspondent | Kulsum Master Smith And Nephew 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2019-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223490782 | K181822 | 000 |