EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES— 510(k) K062171
Substantially EquivalentOrtho Development Corp.
FDA 510(k) clearance K062171 for EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES, Substantially Equivalent on 2007-05-25. Applicant: Ortho Development Corp.. Device class: 2.
Clearance details
- Applicant
- Ortho Development Corp.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
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More clearances from Ortho Development Corp.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.