Thermoforming Sheet Materials (4 models)— 510(k) K241311

Name: FDA 510(k) clearance K241311
Creator: U.S. Food and Drug Administration
Published: 2024-08-02

Substantially Equivalent

Bernhard Förster GmbH

FDA 510(k) clearance K241311 for Thermoforming Sheet Materials (4 models), Substantially Equivalent on 2024-08-02. Applicant: Bernhard Förster GmbH. Device class: Unclassified.

Clearance details

Device name as filed: Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Applicant: Bernhard Förster GmbH
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-05-09
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.