GREAT LAKES PASTE SOLDER— 510(k) K832425

Name: FDA 510(k) clearance K832425
Creator: U.S. Food and Drug Administration
Published: 1983-10-04

Substantially Equivalent

Great Lakes Orthodontics, Ltd.

FDA 510(k) clearance K832425 for GREAT LAKES PASTE SOLDER, Substantially Equivalent on 1983-10-04. Applicant: Great Lakes Orthodontics, Ltd.. Device class: 2.

Clearance details

Applicant: Great Lakes Orthodontics, Ltd.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1983-07-22
Decision date: 1983-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K021367 — STERNGOLD 66, MODEL #11802302002-05-16

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