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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K141637
Device Name SPB SKIN EMULSION
Applicant
Biotd S.A.
816 Congress Ave. - Suite 1400
Austin,  TX  78701
Applicant Contact RICHARD GILLIS, PH.D.
Correspondent
Biotd S.A.
816 Congress Ave. - Suite 1400
Austin,  TX  78701
Correspondent Contact RICHARD GILLIS, PH.D.
Classification Product Code
FRO  
Date Received06/19/2014
Decision Date 06/03/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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