ORTHODONTIC BRACKET/SPEED/HANSON SPEED— 510(k) K801809

Name: FDA 510(k) clearance K801809
Creator: U.S. Food and Drug Administration
Published: 1980-08-13

Substantially Equivalent

Strite Industries , Ltd.

FDA 510(k) clearance K801809 for ORTHODONTIC BRACKET/SPEED/HANSON SPEED, Substantially Equivalent on 1980-08-13. Applicant: Strite Industries , Ltd.. Device class: 1.

Clearance details

Applicant: Strite Industries , Ltd.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1980-07-30
Decision date: 1980-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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