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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Embryo Image Assessment System, Assisted Reproduction
510(k) Number K182798
Device Name KIDScore D3
Applicant
Vitrolife A/S
Jens Juuls Vej 20
Viby J,  DK 8260
Applicant Contact Belinda Dueholm
Correspondent
Vitrolife A/S
Jens Juuls Vej 20
Viby J,  DK 8260
Correspondent Contact Belinda Dueholm
Regulation Number884.6195
Classification Product Code
PBH  
Date Received10/02/2018
Decision Date 07/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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