The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Smith & Nephew Tablet Application.
| Device ID | K190367 |
| 510k Number | K190367 |
| Device Name: | Smith & Nephew Tablet Application |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Smith & Nephew 150 Minuteman Road Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton Smith & Nephew 150 Minuteman Road Andover, MA 01810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-02-15 |
| Decision Date | 2019-05-21 |