RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201— 510(k) K982130
Substantially EquivalentNew Deantronics, Ltd.
FDA 510(k) clearance K982130 for RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201, Substantially Equivalent on 1998-08-07. Applicant: New Deantronics, Ltd..
Clearance details
- Applicant
- New Deantronics, Ltd.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Adverse 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.