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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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510(K)
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smartwedge acl, models 430623, 430628, 430723, 430728, 430823, 430828 BIONX IMPLANTS, LTD. k000616 03/23/2000
shimadzu whole body x-ray computed tomography scanner sct-7800 series SHIMADZU MEDICAL SYSTEMS k994431 03/23/2000
invigra male latex condom green colored and mint flavored INDUS MEDICARE LTD. k000038 03/21/2000
invigra male latex condom yellow colored and banana flavored INDUS MEDICARE LTD. k000039 03/21/2000
invigra male latex condom blue colored and vanilla flavored INDUS MEDICARE LTD. k000040 03/21/2000
videolabs medcam proplus video camera and integral light source VIDEOLABS, INC. k000229 03/21/2000
glypro reagent, glypro calibrator, glypro low control, glypro high control GENZYME CORP. k000239 03/21/2000
specialty 42 (hefilcon a) hydrophilic contact lens for daily wear, specialty t-42 toric (hefilcon a) hydrophilic contact SPECIALTY ULTRAVISION, INC. k000376 03/21/2000
radionics lumboperitoneal shunt RADIONICS, INC. k000057 03/20/2000
modification to hp m2376a device link system AGILENT TECHNOLOGIES, INC. k000635 03/20/2000

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