BLU TOTALE (Model: ENEOB852)— 510(k) K232656
Substantially EquivalentPremier North America, Inc.
FDA 510(k) clearance K232656 for BLU TOTALE (Model: ENEOB852), Substantially Equivalent on 2023-11-14. Applicant: Premier North America, Inc..
Clearance details
- Applicant
- Premier North America, Inc.
- Product code
- Code OLP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lauderdale, FL, 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.