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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessory, assisted reproduction
510(k) Number K173264
Device Name EmbryoScope+
Applicant
Vitrolife A/S
Jens Juuls Vej 20
Viby J,  DK 8260
Applicant Contact Belinda Dueholm
Correspondent
Vitrolife A/S
Jens Juuls Vej 20
DK-8260 Viby J,  DK
Correspondent Contact Belinda Dueholm
Regulation Number884.6120
Classification Product Code
MQG  
Subsequent Product Code
MQK  
Date Received10/11/2017
Decision Date 05/11/2018
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
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