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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K063622
Device Name FINECUBE DENTAL CT
Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
THE YOSHIDA DENTAL MFG. CO., LTD.
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/05/2006
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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