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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 K201667
Device Name Midmark Extraoral Imaging System (EOIS)
Applicant
Midmark Corporation
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Applicant Contact Mark Kenar
Correspondent
Midmark Corporation
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Correspondent Contact Mark Kenar
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received06/19/2020
Decision Date 08/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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