Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes— 510(k) K201533

Name: FDA 510(k) clearance K201533
Creator: U.S. Food and Drug Administration
Published: 2021-03-01

Substantially Equivalent

Avinent Implant System S.L.U.

FDA 510(k) clearance K201533 for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes, Substantially Equivalent on 2021-03-01. Applicant: Avinent Implant System S.L.U.. Device class: 2.

Clearance details

Applicant: Avinent Implant System S.L.U.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2020-06-08
Decision date: 2021-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santpedor, ES

Download summary PDF View on FDA.gov ↗

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