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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K012416
Device Name CONFOSCAN 2 CONFOCAL MICROSCOPE
Applicant
NIDEK TECHNOLOGIES SRL
21911 ERIE LN.
LAKE FOREST,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
NIDEK TECHNOLOGIES SRL
21911 ERIE LN.
LAKE FOREST,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/30/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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