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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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Decision
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wide range c-reactive protein (wr crp) assay STANBIO LABORATORY k041155 10/14/2004
titanium mesh implant INTERPORE CROSS INTL. k041407 12/29/2004
intracavitary mould applicator set, model 189.001 NUCLETRON CORP. k041715 03/24/2005
2 cm peripheral cutting baloon BOSTON SCIENTIFIC IVT k041993 08/16/2004
implantmaster I-DENT k042212 10/21/2004
pre-powdered non-sterile vinyl examination gloves SHANDONG PERFECT PLASTIC CO., LTD. k042213 09/09/2004
powder-free non-sterile vinyl examination gloves SHANDONG PERFECT PLASTIC CO., LTD. k042214 09/15/2004
radiopaque, glass ionomer endodontic cement PREMIER DENTAL PRODUCTS CO. k042215 09/21/2004
cool-tip rf ablation system VALLEYLAB k042216 11/12/2004
flowmedic, model 220 FLOWMEDIC (ISRAEL) LTD k042217 01/12/2005

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