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U.S. Department of Health and Human Services

510(K) Premarket Notification
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nipro safetouch locktail safety fistula needle NIPRO MEDICAL CORP. k093985 01/22/2010
microscan microstrep plus, model b1027-201 SIEMENS HEALTHCARE DIAGNOSTICS k091949 01/26/2010
trailrunner guidewires LAKE REGION MFG., INC. k092965 02/26/2010
angiosculpt pta scoring balloon catheter model 2039-xxyy, 2076-xxyy, 2092-xxyy, 2105-xxyy ANGIOSCORE, INC. k100303 03/22/2010
sureshot tan nails and accessories SMITH & NEPHEW, INC. k092748 04/26/2010
illumina verncode genotyping test for facor v and factor ii ILLUMINA, INC. k093129 04/28/2010
medical plates, lateral plates, posterior lateral plates, olecranon plates model 131218704-708; 851318704-708, 131218204 DEPUY ORTHOPAEDICS, INC. k101421 06/15/2010
powder free vinyl patient examination gloves, colored (white) TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD k100059 07/01/2010
sterile saline solution CACHET PHARMACEUTICALS PVT. LTD. k093367 09/10/2010
geratherm uniqueresc GERATHERM MEDICAL AG k093694 09/20/2010

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