RACE ENDODONTIC FILE— 510(k) K002709

Substantially Equivalent

Amc General, Inc.

FDA 510(k) clearance K002709 for RACE ENDODONTIC FILE, Substantially Equivalent on 2000-11-17. Applicant: Amc General, Inc.. Device class: 1.

Clearance details

Applicant: Amc General, Inc.
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2000-08-30
Decision date: 2000-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Savannah, GA, 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.