The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Pico 7y Single Use Negative Pressure Wound Therapy System.
| Device ID | K182323 |
| 510k Number | K182323 |
| Device Name: | PICO 7Y Single Use Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
| Contact | Shruthi Bhat |
| Correspondent | Kulsum Master Smith & 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 | 2018-08-27 |
| Decision Date | 2019-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223494391 | K182323 | 000 |