The following data is part of a premarket notification filed by Eberle Gmbh & Co. Kg with the FDA for Eberle Shaver System C3 And Accessories.
| Device ID | K193608 |
| 510k Number | K193608 |
| Device Name: | EBERLE Shaver System C3 And Accessories |
| Classification | Arthroscope |
| Applicant | Eberle GmbH & Co. KG Glassbronnenstrasse 6 Wurmberg, DE 75449 |
| Contact | Udo Schniebs |
| Correspondent | Arne Briest VISAMED GmbH Kastellstr. 8 Karlsruhe, DE 76227 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2021-01-15 |