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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K190935
Device Name EZER, Portable X-ray System
Applicant
Livermoretech, Inc.
801 N. Jupiter Rd. Suite 200
Plano,  TX  75074
Applicant Contact Jae Hong Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.1800
Classification Product Code
EHD  
Date Received04/10/2019
Decision Date 12/19/2019
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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