ERO50, ORDER-NO.: 2070— 510(k) K012838

Name: FDA 510(k) clearance K012838
Creator: U.S. Food and Drug Administration
Published: 2001-10-23

Substantially Equivalent

Wieland Edelmetalle GmbH & Co.

FDA 510(k) clearance K012838 for ERO50, ORDER-NO.: 2070, Substantially Equivalent on 2001-10-23. Applicant: Wieland Edelmetalle GmbH & Co.. Device class: 2.

Clearance details

Applicant: Wieland Edelmetalle GmbH & Co.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2001-08-23
Decision date: 2001-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, DE

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