PLASTI-PORE SEPTAL BUTTON— 510(k) K781574

Name: FDA 510(k) clearance K781574
Creator: U.S. Food and Drug Administration
Published: 1978-09-27

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.. Device class: 2.

Clearance details

Applicant: Richard'S Medical Equip., Inc.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
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

Download summary PDF View on FDA.gov ↗

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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.