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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K191125
Device Name ADAS 3D
Applicant
Galgo Medical S.L
C/Comte d'Urgell, 143, 4B
barcelona,  ES 08036
Applicant Contact antoni riu
Correspondent
Galgo Medical S.L
C/Comte d'Urgell, 143, 4B
barcelona,  ES 08036
Correspondent Contact antoni riu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/29/2019
Decision Date 01/15/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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