The following data is part of a premarket notification filed by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge System, Bone Conduction Implant Kit (bci 602 Implant Kit), Bci 602 Sizer Kit, Bci 602 Lifts (1mm).
| Device ID | K191457 |
| 510k Number | K191457 |
| Device Name: | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | MED-EL Elektromedizinische Geraete GmbH Fuestenweg 77a Innsbruck, AT 6020 |
| Contact | Ines Roman Santiago |
| Correspondent | Ines Roman Santiago MED-EL Elektromedizinische Geraete GmbH Fuestenweg 77a Innsbruck, AT 6020 |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-31 |
| Decision Date | 2019-09-18 |