FIBRELIGHT ILLUMINATING ORAL RETRACTORS— 510(k) K854711

Name: FDA 510(k) clearance K854711
Creator: U.S. Food and Drug Administration
Published: 1986-02-25

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K854711 for FIBRELIGHT ILLUMINATING ORAL RETRACTORS, Substantially Equivalent on 1986-02-25. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code EIG
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1985-11-22
Decision date: 1986-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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