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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Color
510(k) Number K072643
Device Name CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
Applicant
OLYMPUS CORPORATION
4-2-1 YUSHIMA, BUNKYO-KU
TOKYO,  JP 113-0034
Applicant Contact FUMIAKI KANAI
Correspondent
OLYMPUS CORPORATION
4-2-1 YUSHIMA, BUNKYO-KU
TOKYO,  JP 113-0034
Correspondent Contact FUMIAKI KANAI
Regulation Number872.3661
Classification Product Code
KZN  
Date Received09/18/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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