OTRES TOOTHBRUSH SANITIZER MODEL TB100W— 510(k) K003517

Name: FDA 510(k) clearance K003517
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Otres, LLC

FDA 510(k) clearance K003517 for OTRES TOOTHBRUSH SANITIZER MODEL TB100W, Substantially Equivalent on 2001-06-06. Applicant: Otres, LLC. Device class: 1.

Clearance details

Applicant: Otres, LLC
Product code: Code MCF
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 2000-11-14
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, 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.