TUF-COAT— 510(k) K892806

Substantially Equivalent

G-C Intl. Corp.

FDA 510(k) clearance K892806 for TUF-COAT, Substantially Equivalent on 1989-07-14. Applicant: G-C Intl. Corp.. Device class: 2.

Clearance details

Applicant: G-C Intl. Corp.
Product code: Code ELL
Device class: Class 2
Regulation: 21 CFR 872.3920
Advisory panel: Dental
Date received: 1989-04-17
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, 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.