XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

Endoilluminator

DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Xenon Brightstar Illumination System, Model 1266.xiii.

Pre-market Notification Details

Device IDK062895
510k NumberK062895
Device Name:XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
ClassificationEndoilluminator
Applicant DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston,  NH  03848
ContactF Carleton
CorrespondentF Carleton
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston,  NH  03848
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-27
Decision Date2006-10-13
Summary:summary

NIH GUDID Devices

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