XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII— 510(k) K062895

Name: FDA 510(k) clearance K062895
Creator: U.S. Food and Drug Administration
Published: 2006-10-13

Substantially Equivalent

Dutch Ophthalmic Research Center International BV

FDA 510(k) clearance K062895 for XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII, Substantially Equivalent on 2006-10-13. Applicant: Dutch Ophthalmic Research Center International BV. Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic Research Center International BV
Product code: Code MPA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-09-27
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

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