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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 K120136
Device Name EMBRYOGEN
Applicant
Origio A/S
15696 Oakstand Rd.
Poway,  CA  92064
Applicant Contact ERIC GRUFF
Correspondent
Origio A/S
15696 Oakstand Rd.
Poway,  CA  92064
Correspondent Contact ERIC GRUFF
Regulation Number884.6180
Classification Product Code
MQL  
Date Received01/17/2012
Decision Date 09/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT00565747
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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