GLUMA(TM) BONDING SYSTEM— 510(k) K871164

Name: FDA 510(k) clearance K871164
Creator: U.S. Food and Drug Administration
Published: 1987-07-02

Substantially Equivalent

Columbus Dental Mfg. Co.

FDA 510(k) clearance K871164 for GLUMA(TM) BONDING SYSTEM, Substantially Equivalent on 1987-07-02. Applicant: Columbus Dental Mfg. Co.. Device class: 2.

Clearance details

Applicant: Columbus Dental Mfg. Co.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1987-03-24
Decision date: 1987-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.