PLASTI-PORE SEPTAL BUTTON— 510(k) K781574

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K781574 for PLASTI-PORE SEPTAL BUTTON, Substantially Equivalent on 1978-09-27. Applicant: Richard'S Medical Equip., Inc..

Clearance details

Applicant: Richard'S Medical Equip., Inc.
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 1978-09-18
Decision date: 1978-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.