ZANLEX, ZAN-TEX & ZANDEX— 510(k) K830511

Name: FDA 510(k) clearance K830511
Creator: U.S. Food and Drug Administration
Published: 1983-03-17

Substantially Equivalent

Winn Hirsch & Assoc.

FDA 510(k) clearance K830511 for ZANLEX, ZAN-TEX & ZANDEX, Substantially Equivalent on 1983-03-17. Applicant: Winn Hirsch & Assoc.. Device class: 1.

Clearance details

Applicant: Winn Hirsch & Assoc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1983-02-17
Decision date: 1983-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainview, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.