FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR— 510(k) K061228

Name: FDA 510(k) clearance K061228
Creator: U.S. Food and Drug Administration
Published: 2006-05-26

Substantially Equivalent

Bryan Keropian Dds

FDA 510(k) clearance K061228 for FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR, Substantially Equivalent on 2006-05-26. Applicant: Bryan Keropian Dds. Device class: 2.

Clearance details

Applicant: Bryan Keropian Dds
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2006-05-02
Decision date: 2006-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarzana, CA, US

Download summary PDF View on FDA.gov ↗

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