OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K— 510(k) K083720
Substantially EquivalentBien-Air Surgery SA
FDA 510(k) clearance K083720 for OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K, Substantially Equivalent on 2009-03-20. Applicant: Bien-Air Surgery SA.
Clearance details
- Applicant
- Bien-Air Surgery SA
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Noirmont, CH
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.