KELES FACEMASK— 510(k) K041718

Substantially Equivalent

Great Lakes Orthodontics, Ltd.

FDA 510(k) clearance K041718 for KELES FACEMASK, Substantially Equivalent on 2004-10-15. Applicant: Great Lakes Orthodontics, Ltd.. Device class: 2.

Clearance details

Applicant: Great Lakes Orthodontics, Ltd.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 2004-06-24
Decision date: 2004-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, 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.