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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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eg-3630ur, ultrasund video gastroscope PENTAX PRECISION INSTRUMENT CORP. k013640 02/04/2002
aurelia chlorinated powder free latex medical examination gloves with aloe vera and ginseng with protein labeling claim SUPERMAX GLOVE MANUFACTURING SDN BHD k013953 02/26/2002
vaporized hydrogen peroxide (vhp) sterilization of unmwpe components in the cofield total shoulder system, the neer ii SMITH & NEPHEW, INC. k012788 03/15/2002
simidur s2 WIELAND DENTAL + TECHNIK GMBH & CO. KG k020192 03/15/2002
s2 femoral nail HOWMEDICA OSTEONICS CORP. k021026 04/25/2002
verdict-ii propoxyphene MEDTOX DIAGNOSTICS, INC. k020787 05/02/2002
replace ha coated implant, models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 NOBEL BIOCARE UAS INC k020646 05/29/2002
uhi-3 high flow insufflation unit OLYMPUS OPTICAL CO., LTD. k014166 06/25/2002
sterile powder free latex examination gloves with protein claim less than 50u/g of gloves SMART GLOVE CORP. SDN BHD k021521 07/02/2002
chad therapeutics oxypenumatic cypress model 511 CHAD THERAPEUTICS, INC. k020475 07/05/2002

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