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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 K113075
Device Name EMBRYO VIEWER SOFTWARE
Original Applicant
UNISENSE FERTILITECH A/S
tueager 1
arrhus n,  DK dk-8200
Original Contact mette munch
Regulation Number884.6120
Classification Product Code
MQG  
Date Received10/17/2011
Decision Date 12/21/2011
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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