The following data is part of a premarket notification filed by Bien-air Surgery Sa with the FDA for Osseoduo, Shaver Handpiece S80 And S120, Micromotor 80k.
| Device ID | K083720 |
| 510k Number | K083720 |
| Device Name: | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | BIEN-AIR SURGERY SA RUE DE L'OUEST 2B Le Noirmont, CH 2340 |
| Contact | Hugues Froidevaux |
| Correspondent | Hugues Froidevaux BIEN-AIR SURGERY SA RUE DE L'OUEST 2B Le Noirmont, CH 2340 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-03-20 |
| Summary: | summary |