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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 K133912
Device Name ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
Applicant
Origio A/S
Knardrupvej 2
Maaloev,  DK DK-2760
Applicant Contact TOVE KJAER
Correspondent
Origio A/S
Knardrupvej 2
Maaloev,  DK DK-2760
Correspondent Contact TOVE KJAER
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/23/2013
Decision Date 05/14/2014
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 Yes
Predetermined Change
Control Plan Authorized		 No
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