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.. Device class: 2.
Clearance details
- Applicant
- Premier North America, Inc.
- Product code
- Code OLP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lauderdale, FL, US
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More clearances from Premier North America, Inc.
view allAdverse 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.