ORTHODONITC METAL REINFORCED PLASTIC BRACKET— 510(k) K942826

Name: FDA 510(k) clearance K942826
Creator: U.S. Food and Drug Administration
Published: 1994-12-14

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K942826 for ORTHODONITC METAL REINFORCED PLASTIC BRACKET, Substantially Equivalent on 1994-12-14. Applicant: Gac Intl., Inc.. Device class: 2.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1994-06-14
Decision date: 1994-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, 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.