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U.S. Department of Health and Human Services

510(K) Premarket Notification

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ldr spine roi-c implant LDR SPINE USA k080728 05/29/2008
xia spinal system, stainless steel uni-planar screws STRYKER SPINE k080928 04/30/2008
buprenorphine enzyme immunoassay, calibrators and controls for beckman coulter synchron systems Lin-Zhi International, Inc. k081008 12/22/2008
tcm endo 20 NOUVAG AG k081191 08/07/2008
liaison hsv-1 type specific igg assay, control hsv-1 igg DIASORIN, INC. k081685 11/18/2008
temporary tooth replacement ORMCO CORP. k081900 10/24/2008
modification to fetch aspiration catheter POSSIS MEDICAL, INC. k081989 09/26/2008
coulter body fluid control BECKMAN COULTER, INC. k082162 02/03/2009
visionsense stereoscopic vision system VISIONSENSE, LTD. k082355 12/15/2008
powder-free vinyl patient examination gloves, clear (non-colored) TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD k082597 10/24/2008

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