GLOBAL TREASURES FLUID FILLED TEETHER— 510(k) K043033

Name: FDA 510(k) clearance K043033
Creator: U.S. Food and Drug Administration
Published: 2005-03-22

Substantially Equivalent

Global Treasure Industries , Ltd.

FDA 510(k) clearance K043033 for GLOBAL TREASURES FLUID FILLED TEETHER, Substantially Equivalent on 2005-03-22. Applicant: Global Treasure Industries , Ltd.. Device class: 2.

Clearance details

Applicant: Global Treasure Industries , Ltd.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2004-11-03
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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