SHUR GEL 4— 510(k) K860855

Substantially Equivalent

Columbus Dental Mfg. Co.

FDA 510(k) clearance K860855 for SHUR GEL 4, Substantially Equivalent on 1986-06-16. 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: 1986-03-07
Decision date: 1986-06-16
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.