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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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reverso MEDISYSTEMS CORP. k994306 03/20/2000
nuvasive townley facet screw NUVASIVE, INC. k994308 04/18/2000
solo ortho 2 SYBRON DENTAL SPECIALTIES, INC. k994309 03/17/2000
male latex condom with vanilla flavor PLEASURE LATEX PRODUCTS SDN. BHD. k994311 03/21/2000
male latex condom 56mm PLEASURE LATEX PRODUCTS SDN. BHD. k994312 03/21/2000
modification to bone anchor and kit (bak) AXYA MEDICAL, INC. k994313 01/13/2000
castle series 100hc steam sterilizers GETINGE/CASTLE, INC. k994314 02/16/2000
cp peripheral angio array coil/ magnetom symphony system SIEMENS MEDICAL SOLUTIONS USA, INC. k994315 02/04/2000
magnetom open viva with permanent magnet SIEMENS MEDICAL CORP. k994316 01/14/2000
i-plant, model 3500 IMPLANT SCIENCES CORP. k994317 03/21/2000

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