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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 K133712
Device Name EMBRYOVIEWER SOFTWARE
Applicant
UNISENSE FERTILITECH A/S
TUEAGER 1
AARHUS N,  DK DK-8200
Applicant Contact Henrik Wahlgren
Correspondent
UNISENSE FERTILITECH A/S
TUEAGER 1
AARHUS N,  DK DK-8200
Correspondent Contact Henrik Wahlgren
Regulation Number884.6120
Classification Product Code
MQG  
Date Received12/05/2013
Decision Date 08/08/2014
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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