CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US


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

Correspodent Contact fumiaki kanai
Regulation Number 872.3661
Classification Product Code
KZN  
Date Received 09/18/2007
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