FAgamin®— 510(k) K240059

Substantially Equivalent

Tedequim Srl

FDA 510(k) clearance K240059 for FAgamin®, Substantially Equivalent on 2024-05-16. Applicant: Tedequim Srl. Device class: 2.

Clearance details

Applicant: Tedequim Srl
Product code: Code PHR
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2024-01-08
Decision date: 2024-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Córdoba, AR

Download summary PDF View on FDA.gov ↗

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