SHUR GEL— 510(k) K830083

Substantially Equivalent

Columbus Dental Mfg. Co.

FDA 510(k) clearance K830083 for SHUR GEL, Substantially Equivalent on 1983-02-07. Applicant: Columbus Dental Mfg. Co.. Device class: 2.

Clearance details

Applicant: Columbus Dental Mfg. Co.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1983-01-11
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.