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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K112380
Device Name CLEARVISION
Applicant
Midmark Corp.
675 Heathrow Dr.
Lincolnshire,  IL  60069
Applicant Contact LISA BARTAKOVICS
Correspondent
Midmark Corp.
675 Heathrow Dr.
Lincolnshire,  IL  60069
Correspondent Contact LISA BARTAKOVICS
Regulation Number872.1800
Classification Product Code
MUH  
Date Received08/17/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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