BENACEL— 510(k) K090612
Substantially EquivalentUnicare Biomedical
FDA 510(k) clearance K090612 for BENACEL, Substantially Equivalent on 2009-07-24. Applicant: Unicare Biomedical. Device class: Unclassified.
Clearance details
- Applicant
- Unicare Biomedical
- Product code
- Code OLR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
Recent devices under product code OLR
view allMore clearances from Unicare Biomedical
view allAdverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
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.