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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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spectra-glass lor (loss of resistance syringe, 5cc metal l/s or l/l tip, spectra-glass lor (loss of resistance) syringe SPECTRA MEDICAL DEVICES, INC. k082674 11/28/2008
ezvue (ocufilcon d) soft (hydrophilic) contact lens for daily wear I-SEE VISION TECHNOLOGY INC k082879 06/16/2009
fully automated electronic blood pressure monitor, model kd-7906 ANDON HEALTH CO.,LTD k083247 01/29/2009
fixit headrest clamp system MEDICON, E.G. k083803 03/10/2010
isolyser home sharps management (hsm), model 800m; isoly sharps management system (sms), models 2400m, 4000m, 10000m, 5. WCM WASTE & COMPLIANCE MANAGEMENT, INC. k090157 05/04/2009
hemosil d-dimer hs 500, controls INSTRUMENTATION LABORATORY CO. k090264 02/05/2010
power processor sample processing system with generic connection module, model: 4210 BECKMAN COULTER, INC. k090588 05/27/2009
inomax ds (delivery system) INO THERAPEUTICS LLC k090958 06/18/2009
revolution femoral intramedullary nail system, model dgooxx DGIMED ORTHO, INC k091309 11/05/2009
slicks sectional matrix and matrix bands, models sm100, sm150, sm175, sm200, sm300, smh100, smh150, smh175 and smh200 GARRISON DENTAL SOLUTIONS k091533 08/17/2009

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