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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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modification to: cd horizon spinal system MEDTRONIC SOFAMOR DANEK k043151 02/01/2005
vertebron pss pedicle screw system VERTEBRON, INC. k043152 02/01/2005
biscover lv BISCO, INC. k043168 02/01/2005
nobelrondo dental ceramic - zirconia NOBEL BIOCARE USA, LLC k043312 02/01/2005
d 905 eos hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir DIDECO S.R.L. k043323 02/01/2005
powder-free vinyl patient examination gloves, white (non-colored) SHIJIAZHUANG WINFUL PLASTIC CO., LTD. k043475 02/01/2005
modification to: cd horizon spinal system MEDTRONIC SOFAMOR DANEK k043321 02/03/2005
syngo inspace 4d SIEMENS AG, MEDICAL SOLUTIONS k043469 02/03/2005
stealth fusion system, model rr 1000 R&R MEDICAL, INC. k043174 02/07/2005
rabea spinal implant SIGNUS MEDIZINTECHNIK GMBH k043316 02/07/2005

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