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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoilluminator
510(k) Number K062895
Device Name XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
Applicant
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
ONE LITTLE RIVER RD.
KINGSTON,  NH  03848
Applicant Contact F CARLETON
Correspondent
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
ONE LITTLE RIVER RD.
KINGSTON,  NH  03848
Correspondent Contact F CARLETON
Regulation Number876.1500
Classification Product Code
MPA  
Date Received09/27/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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