MASSAGER, GUM/SSAGE POWERED GUM— 510(k) K780360
Substantially EquivalentSunbeam Corp.
FDA 510(k) clearance K780360 for MASSAGER, GUM/SSAGE POWERED GUM, Substantially Equivalent on 1978-05-26. Applicant: Sunbeam Corp.. Device class: 1.
Clearance details
- Applicant
- Sunbeam Corp.
- Product code
- Code JEQ
- Device class
- Class 1
- Regulation
- 21 CFR 872.6865
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Sunbeam Corp.
view allAdverse events under product code JEQ
product code JEQ- Injury
- 188
- Malfunction
- 2,818
- Total
- 3,006
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.