EKONIC DENTAL/MEDICAL MASK (MD 610)— 510(k) K970440

Substantially Equivalent

Ekonic Company, Ltd.

FDA 510(k) clearance K970440 for EKONIC DENTAL/MEDICAL MASK (MD 610), Substantially Equivalent on 1997-03-27. Applicant: Ekonic Company, Ltd..

Clearance details

Applicant: Ekonic Company, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1997-02-05
Decision date: 1997-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carver, MA, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.