The following data is part of a premarket notification filed by Needlesmart Limited with the FDA for Needlesmart Professional (ns Pro).
| Device ID | K202073 |
| 510k Number | K202073 |
| Device Name: | NeedleSmart Professional (NS Pro) |
| Classification | Sharps Needle Destruction Device |
| Applicant | NeedleSmart Limited Suite 2B, Stanley Grange Business Park, Ormskirk Road, Knowsley, Prescot, GB L34 5nb |
| Contact | Tom Baker |
| Correspondent | Tom Baker NeedleSmart Limited Suite 2B, Stanley Grange Business Park, Ormskirk Road, Knowsley, Prescot, GB L34 5nb |
| Product Code | MTV |
| CFR Regulation Number | 880.6210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2021-03-25 |