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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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hycure oral / hycure oral smart gel THE HYMED GROUP CORP. k994339 03/22/2000
finecross mg coronary micro-guide catheter TERUMO MEDICAL CORP. k082519 09/26/2008
single use guidewire, models g-240-2527s, g-240-2545s, g-240-2527a, g-240-2545a, g-240-3527s, g-240-3545s & g-240-3527a TERUMO CORP. k091417 05/22/2009
terumo surguard 3 safety needle terumo surguard 3 hypodermic syringe with safety needle TERUMO (PHILIPPINES) CORPORATION k113422 03/05/2012
distal clavicular fragment immobilization plate left, model 1810-116_126-03 (05,07) right 1811-116_126-03 (05,07) TERRAY CORP. k063275 07/27/2007
iivs integrated image viewing station TERARECON, INC. k994329 05/26/2000
tekmedic powder-free latex examination gloves with protein content labeling claim (50 micrograms or less) TEKMEDIC (M) SDN BHD k994250 02/07/2000
powder free vinyl patient examination gloves, colored (yellow) TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD k100058 03/05/2010
clever chek td-4230 blood glucose monitoring system, rd-4230, surechek blood glucose monitoring system, sms-4230 TaiDoc Technology Corporation k070472 03/15/2007
synthes 3.0mm headless compression screws SYNTHES (USA) k050636 04/21/2005

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