KLEIN HANDLE— 510(k) K881783

Substantially Equivalent

E.L. Medico Intl., Inc.

FDA 510(k) clearance K881783 for KLEIN HANDLE, Substantially Equivalent on 1988-12-02. Applicant: E.L. Medico Intl., Inc..

Clearance details

Applicant: E.L. Medico Intl., Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1988-04-26
Decision date: 1988-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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Adverse events under product code GDM

product code GDM

Death: 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.