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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 K133707
Device Name SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
Applicant
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Applicant Contact TOVE KJAER
Correspondent
Origio A/S
Knardrupvej 2
Måløv,  DK 2760
Correspondent Contact TOVE KJAER
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/04/2013
Decision Date 04/16/2014
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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