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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K041805
Device Name MICROSCOPE SYSTEM
Applicant
Miras Mirror Imaging Solutions, Ltd.
11 Menachem Begin St.
Ramat-Gan,  IL
Applicant Contact DORIT WINITZ PH.D.
Correspondent
Miras Mirror Imaging Solutions, Ltd.
11 Menachem Begin St.
Ramat-Gan,  IL
Correspondent Contact DORIT WINITZ PH.D.
Regulation Number872.6640
Classification Product Code
EIA  
Date Received07/06/2004
Decision Date 09/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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