FS Ergo— 510(k) K173646

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K173646 for FS Ergo, Substantially Equivalent on 2017-12-19. Applicant: Palodex Group OY. Device class: 2.

Clearance details

Applicant: Palodex Group OY
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2017-11-27
Decision date: 2017-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.