R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose— 510(k) K192913

Name: FDA 510(k) clearance K192913
Creator: U.S. Food and Drug Administration
Published: 2021-01-19

Substantially Equivalent

Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

FDA 510(k) clearance K192913 for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose, Substantially Equivalent on 2021-01-19. Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Device class: 2.

Clearance details

Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2019-10-15
Decision date: 2021-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Konya, TR

Download summary PDF View on FDA.gov ↗

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