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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Applicant
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510(K)
Number
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Decision
Date
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shimadzu whole body x-ray computed tomography scanner sct-7800 series SHIMADZU MEDICAL SYSTEMS k994431 03/23/2000
shimadzu mobile x-ray system mux-100 series SHIMADZU CORP. k001517 06/27/2000
synthetic powder free (white) vinyl patient examination gloves SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD k000071 02/29/2000
synthetic (white) vinal powdered patient examination gloves SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD k000166 02/22/2000
royal shield non-sterile purple (pink/blue) colored powdered latex exam with protein labeling claim [<200 mcg or less] w SHIELD GLOVES MANUFACTURER (M) SDN BHD k000217 02/18/2000
shield von willebrand factor activity elisa, model fvwf 200 SHIELD DIAGNOSTICS, LTD. k000398 04/17/2000
disposable powder free nitrile exam gloves, white color SHEEN MORE ENT. CO., LTD. k000226 03/02/2000
disposable powdered nitrile exam glove, white color SHEEN MORE ENT. CO., LTD. k001155 05/23/2000
multiple private labels, nitrile exam gloves, powder-free (white) SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. k001549 06/12/2000
vital shield gold powdered latex examination gloves with protein content labeling claim (200 micrograms or less) SGMP CO., LTD. k000390 04/12/2000

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