DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES— 510(k) K993777
Substantially EquivalentR-Group Intl.
FDA 510(k) clearance K993777 for DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES, Substantially Equivalent on 2000-05-25. Applicant: R-Group Intl..
Clearance details
- Applicant
- R-Group Intl.
- Product code
- Code HGI
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Adverse events under product code HGI
product code HGI- 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.