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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
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concept hp add-on; concept hp enamel IVOCLAR VIVADENT AG k033773 01/15/2004
shiraz-java spinal fixation system SPINE NEXT AMERICA k033772 01/27/2004
bawmed e-z bag resuscitator BAWMED UK k031434 02/06/2004
eius unicompartmental knee system HOWMEDICA OSTEONICS CORP k033769 02/13/2004
altus medical optional infrared handpiece ALTUS MEDICAL, INC. k033768 02/17/2004
zimmer ortho guidance systems- hip instruments ZIMMER, INC. k033223 02/18/2004
dual top anchor system screws JEIL MEDICAL CORPORATION k033767 02/24/2004
bio-detek modified adult multi-function electrode with connector BIO-DETEK, INC. k033771 02/27/2004
sp newtron module SATELEC k033764 03/01/2004
ct-mass MEDIS MEDICAL IMAGING SYSTEMS, B.V. k033774 03/02/2004

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