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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, reproductive
510(k) Number K153267
Device Name ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
Applicant
ORIGIO A/S
KNARDRUPVEJ 2
MALOV,  DK 2760
Applicant Contact Tove Kjaer
Correspondent
ORIGIO A/S
KNARDRUPVEJ 2
MALOV,  DK 2760
Correspondent Contact Tove Kjaer
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/12/2015
Decision Date 07/22/2016
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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