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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name cord blood processing system and storage container
510(K) Number BK060036
Device Name Sepax Cell Separation System and Single Use Kits
Product CodeOAO
Device ClassII
Regulation Number864.9900
Submission Type 510(k) Traditional
Requestor
Biosafe SA
route du petit-eysins
eysins,  Vaud  CH 1262
Date Received06/15/2006
Decision Date 01/03/2007
DecisionDENOVOGRANT
Expedited Review No
Third Party Review Not Third Party Elligble
In Vitro Device? No
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