IST SNORING APPLIANCE— 510(k) K090911

Substantially Equivalent

Dental Crafters

FDA 510(k) clearance K090911 for IST SNORING APPLIANCE, Substantially Equivalent on 2009-09-11. Applicant: Dental Crafters. Device class: 2.

Clearance details

Applicant: Dental Crafters
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2009-04-01
Decision date: 2009-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfeld, WI, 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.