RETAINER, SCREW EXPANSION ORTHODONTIC— 510(k) K903498

Name: FDA 510(k) clearance K903498
Creator: U.S. Food and Drug Administration
Published: 1991-03-12

Substantially Equivalent

Masel Industries, Inc.

FDA 510(k) clearance K903498 for RETAINER, SCREW EXPANSION ORTHODONTIC, Substantially Equivalent on 1991-03-12. Applicant: Masel Industries, Inc.. Device class: 1.

Clearance details

Applicant: Masel Industries, Inc.
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1990-08-03
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, PA, 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.