HERAENIUM CA— 510(k) K851515

Substantially Equivalent

Heraeus Dental Gold Corp.

FDA 510(k) clearance K851515 for HERAENIUM CA, Substantially Equivalent on 1985-09-23. Applicant: Heraeus Dental Gold Corp.. Device class: 2.

Clearance details

Applicant: Heraeus Dental Gold Corp.
Product code: Code EJH
Device class: Class 2
Regulation: 21 CFR 872.3710
Advisory panel: Dental
Date received: 1985-04-15
Decision date: 1985-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Queens Village, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.