Rotium— 510(k) K250021

Substantially Equivalent

Nanofiber Solutions, LLC

FDA 510(k) clearance K250021 for Rotium, Substantially Equivalent on 2025-02-27. Applicant: Nanofiber Solutions, LLC.

Clearance details

Applicant: Nanofiber Solutions, LLC
Product code: Code OWW
Advisory panel: General, Plastic Surgery
Date received: 2025-01-03
Decision date: 2025-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, OH, US

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