Sectum— 510(k) K202780

Substantially Equivalent

Neauvia North America

FDA 510(k) clearance K202780 for Sectum, Substantially Equivalent on 2021-07-30. Applicant: Neauvia North America. Device class: 2.

Clearance details

Applicant: Neauvia North America
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2020-09-22
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raliegh, NC, US

Download summary PDF View on FDA.gov ↗

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