HYCURE ORAL / HYCURE ORAL SMART GEL— 510(k) K994339

Substantially Equivalent

The Hymed Group Corp.

FDA 510(k) clearance K994339 for HYCURE ORAL / HYCURE ORAL SMART GEL, Substantially Equivalent on 2000-03-22. Applicant: The Hymed Group Corp..

Clearance details

Applicant: The Hymed Group Corp.
Product code: Code KGN
Advisory panel: Unknown
Date received: 1999-12-23
Decision date: 2000-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.