Ion 3D— 510(k) K241416

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K241416 for Ion 3D, Substantially Equivalent on 2024-06-17. Applicant: SurGenTec, LLC. Device class: Unclassified.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-05-17
Decision date: 2024-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Boca Raton, FL, 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.