PERMADYNE POLYETHER RUBBER IMPRESSION— 510(k) K800031

Name: FDA 510(k) clearance K800031
Creator: U.S. Food and Drug Administration
Published: 1980-02-05

Substantially Equivalent

Espe Dental Products

FDA 510(k) clearance K800031 for PERMADYNE POLYETHER RUBBER IMPRESSION, Substantially Equivalent on 1980-02-05. Applicant: Espe Dental Products. Device class: 2.

Clearance details

Applicant: Espe Dental Products
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1980-01-07
Decision date: 1980-02-05
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.