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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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fin-s microimplant CREEKSIDE ORTHODONTICS k120861 02/21/2013
scenium 2.0 SIEMENS MEDICAL SOLUTIONS USA, INC. k121074 06/08/2012
wandy dispersvie electrode BIO-MED USA INC. k121268 12/20/2012
nuk expressivetm double electric breast pump MAPA GMBH k121478 04/05/2013
burn resuscitation decision support system (brdss) ARCOS, INC. k121659 04/18/2013
access accutni reagent, access accutni calibrator, unicel dxi 800 access immunoassay system BECKMAN COULTER, INC. k121790 09/25/2013
distal femoral growing prosthesis, tibial rotating components, bearing, axis, circlip, wedge HOWMEDICA OSTEONICS CORP. k122015 02/22/2013
varisourse ix brahytherapy afterloader varisource ix (t) brachytherapy afterloader VARIAN MEDICAL SYSTEMS, INC. k122236 11/16/2012
encircle compression therapy stocking ENCIRCLE MEDICAL DEVICES LTD. k122485 04/23/2013
inner peace KAMABRY, INC., DBA INNER PEACE FOR WOMEN k122800 10/04/2013

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