The following data is part of a premarket notification filed by Bien-air Surgery Sa with the FDA for Osseostap Microdrill System (control Unit And Handpiece), Osseostap Control Unit (foot Pedal), Osseostap Handpiece.
| Device ID | K143492 |
| 510k Number | K143492 |
| Device Name: | OSSEOSTAP Microdrill System (control Unit And Handpiece), OSSEOSTAP Control Unit (foot Pedal), OSSEOSTAP Handpiece |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Bien-Air Surgery SA Rue De L'Ouest 2b Le Noirmont, CH 2340 |
| Contact | Judith Clerc |
| Correspondent | Roland Hasler 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 | 2014-12-08 |
| Decision Date | 2015-03-04 |
| Summary: | summary |