LIGHT GUIDE CABLE— 510(k) K111342

Substantially Equivalent

Schott North America

FDA 510(k) clearance K111342 for LIGHT GUIDE CABLE, Substantially Equivalent on 2011-11-25. Applicant: Schott North America. Device class: 2.

Clearance details

Applicant: Schott North America
Product code: Code HBI
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2011-05-13
Decision date: 2011-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.