VISIONARY 2000— 510(k) K000639
Substantially EquivalentBurton Medical Products Corp.
FDA 510(k) clearance K000639 for VISIONARY 2000, Substantially Equivalent on 2000-05-25. Applicant: Burton Medical Products Corp..
Clearance details
- Applicant
- Burton Medical Products Corp.
- Product code
- Code FSY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chatsworth, CA, US
Adverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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.