PRE-DENT— 510(k) K791200
Substantially EquivalentFichte, Graves, and Hunt
FDA 510(k) clearance K791200 for PRE-DENT, Substantially Equivalent on 1979-08-10. Applicant: Fichte, Graves, and Hunt. Device class: 2.
Clearance details
- Applicant
- Fichte, Graves, and Hunt
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
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.