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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, assisted reproduction
510(k) Number K161547
Device Name Transem and EchoGen Embryo Transfer Catheters
Applicant
ORIGIO A/S
KNARDRUPVEJ 2
MAALOEV,  DK 2760
Applicant Contact TOVE KJAER
Correspondent
ORIGIO A/S
KNARDRUPVEJ 2
MAALOEV,  DK 2760
Correspondent Contact TOVE KJAER
Regulation Number884.6110
Classification Product Code
MQF  
Date Received06/03/2016
Decision Date 03/09/2017
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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