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U.S. Department of Health and Human Services

510(K) Premarket Notification
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integra (r) jarit (r) kerrison rongeurs, integra (r) ruggles (tm)-redmons (tm) kerrison rongeurs, integra (r) miltex (r) kerrison rongeurs, integra (r) meisterhand (r) kerrison rongeurs Integra Lifesciences Corp. k150428 04/16/2015
eva,anterior machine, eva, combined machine, eva combined machine with laser(dorc connector), eva combined machine with laser sma connector) Dutch Ophthalmic Research Center International BV k142877 03/13/2015
medical monofilament sensory screening toool Medical Monofilament Manufacturing k143068 01/14/2015
new era orthopaedics polyscrew pedicle screw system New Era Orthopaedics, LLC k141253 01/09/2015
uni npwt foam dressing kit, uni npwt foam dressing kit, uni npwt foam dressing kit Blue Ocean Medical Product, LLC k133333 12/31/2014
pilot pro diode laser CAO Group, Inc. k142223 09/12/2014
biodentine Septodont k140132 06/27/2014
spiral flow vascular arteriovenous graft Vascular Flow Technologies, Ltd. k141124 05/30/2014
cera-chek 1070 blood glucose monitoring system Ceragem Medisys, Inc. k131727 02/28/2014
scintillant dual bent tip surgical light, scintillant dual straight tip surgical light Engineered Medical Solutions Co., LLC k133425 12/05/2013

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