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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 K122643
Device Name VANTAGE MODEL V5000, V5100, V5000C, V5100C
Applicant
Midmark Corp.
675 Heathrow Dr.
Lincolnshire,  IL  60069
Applicant Contact MARK GREENWOOD
Correspondent
Midmark Corp.
675 Heathrow Dr.
Lincolnshire,  IL  60069
Correspondent Contact MARK GREENWOOD
Regulation Number872.1800
Classification Product Code
MUH  
Date Received08/29/2012
Decision Date 01/07/2013
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
Recalls CDRH Recalls
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