QUASAR CALYPSO— 510(k) K111286
Substantially EquivalentSilver Bay, LLC
FDA 510(k) clearance K111286 for QUASAR CALYPSO, Substantially Equivalent on 2012-01-18. Applicant: Silver Bay, LLC.
Clearance details
- Applicant
- Silver Bay, LLC
- Product code
- Code OLP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, US
Adverse events under product code OLP
product code OLP- Other
- 1
- Total
- 1
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.