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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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powdered latex examination gloves with protein labeling claim (contains 200 micrograms or less of total water extractabl SPI GLOVES SDN. BHD. k050527 03/18/2005
rap/tac/csa control - level 1,2,3,4 MORE DIAGNOSTICS k050125 03/18/2005
imagenpro CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC k050366 03/17/2005
stabilization screw NEWDEAL S.A. k050346 03/17/2005
stryker mmf screw STRYKER INSTRUMENTS k050535 03/17/2005
polymer coated powder free nitrile examination gloves (blue,white,violet, pink,green) SPI GLOVES SDN. BHD. k050530 03/16/2005
ultra mirage ii mask RESMED LTD. k050359 03/16/2005
enfanttm DIOPSYS INC. k043491 03/16/2005
aequalis reversed shoulder prosthesis TORNIER k050316 03/16/2005
polymer coated powder free latex examination gloves with protein labeling claim (contains 50 micrograms or less of toter SPI GLOVES SDN. BHD. k050529 03/16/2005

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