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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K191491
Device Name EZ-Cover
Applicant
Medxpress.Pro
Slachthuislaan 1, Bus 102
Leuven,  BE 3000
Applicant Contact Katherine Hughey
Correspondent
Lean TO Quality, LLC
107 Ave. A
Willis,  TX  77378
Correspondent Contact Jeff Kasoff
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/05/2019
Decision Date 06/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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