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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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eti-ea-g assay DIASORIN, INC. k992191 07/12/1999
excel ultra-hi formula heat-cured denture base material ST. GEORGE TECHNOLOGY, INC. k992176 02/10/2000
exel injection plug with cap EXEL INTL. k992290 02/23/2000
extra-care latex patient examination glove, powder-free, polymer coated ULTRAWIN SDN BHD k992175 09/24/1999
eye-q (xylofilcon a) soft (hydrophilic) multifocal contact lens for daily wear SOFLEX CONTACT LENS INDUSTRIES LTD. k013469 11/20/2001
ez-mio sternal VIDACARE CORPORATION k063567 01/26/2007
first check multi drug cup 7 for marijuana (thc), cocaine (coc), amphetamine (amp), methamphetamine (met), ecstasy WORLDWIDE MEDICAL LLC k051966 09/07/2005
first response 1-step pregnancy ARMKEL, LLC. k992232 12/21/1999
first step unicompartmental knee system HOWMEDICA OSTEONICS CORP. k992287 11/16/1999
flashlite rebel* DISCUS DENTAL, INC. k073518 12/20/2007

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