The following data is part of a premarket notification filed by Sutter Medizintechnik Gmbh with the FDA for Sutter Ravor Bipolar Electrodes.
| Device ID | K191732 |
| 510k Number | K191732 |
| Device Name: | Sutter RaVoR Bipolar Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Sutter Medizintechnik GmbH Tullastrasse 87 Freiburg, DE 79108 |
| Contact | Ulrike Zeissler |
| Correspondent | Ulrike Zeissler Sutter Medizintechnik GmbH Tullastrasse 87 Freiburg, DE 79108 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2019-08-30 |