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 |