InnoGenic Non-resorbable Membrane— 510(k) K211554

Name: FDA 510(k) clearance K211554
Creator: U.S. Food and Drug Administration
Published: 2023-02-24

Substantially Equivalent

Cowellmedi Co., Ltd.

FDA 510(k) clearance K211554 for InnoGenic Non-resorbable Membrane, Substantially Equivalent on 2023-02-24. Applicant: Cowellmedi Co., Ltd.. Device class: 2.

Clearance details

Applicant: Cowellmedi Co., Ltd.
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2021-05-19
Decision date: 2023-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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