FLOSSAGE - ELECTRIC TOOTHFLOSSER— 510(k) K850562

Substantially Equivalent

Mcspadden, Inc.

FDA 510(k) clearance K850562 for FLOSSAGE - ELECTRIC TOOTHFLOSSER, Substantially Equivalent on 1985-03-27. Applicant: Mcspadden, Inc..

Clearance details

Applicant: Mcspadden, Inc.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1985-02-12
Decision date: 1985-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson City, TN, US

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Adverse events under product code JEQ

product code JEQ

Injury: 188
Malfunction: 2,818
Total: 3,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.