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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 Avenue 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
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