Blue Sky Bio TAD— 510(k) K201919
Substantially EquivalentBlue Sky Bio, LLC
FDA 510(k) clearance K201919 for Blue Sky Bio TAD, Substantially Equivalent on 2020-12-17. Applicant: Blue Sky Bio, LLC.
Clearance details
- Applicant
- Blue Sky Bio, LLC
- Product code
- Code OAT
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Adverse events under product code OAT
product code OAT- Injury
- 355
- Total
- 355
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.