SurgiCube— 510(k) K163455

Substantially Equivalent

Surgicube International B.V.

FDA 510(k) clearance K163455 for SurgiCube, Substantially Equivalent on 2017-09-28. Applicant: Surgicube International B.V.. Device class: 2.

Clearance details

Applicant: Surgicube International B.V.
Product code: Code ORC
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Date received: 2016-12-09
Decision date: 2017-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vierpolders, NL

Download summary PDF View on FDA.gov ↗

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