The following data is part of a premarket notification filed by Tellos Medical Ab with the FDA for Tellos Isq Buddy.
| Device ID | K143445 |
| 510k Number | K143445 |
| Device Name: | Tellos ISQ Buddy |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Tellos Medical AB Nedergardsgatan 5 Goteborg, SE 41654 |
| Contact | Anders Petersson |
| Correspondent | Anders Petersson Tellos Medical AB Nedergardsgatan 5 Goteborg, SE 41654 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2016-01-07 |
| Summary: | summary |