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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 43 of 43 Results
ProductCode: JWH Applicant: SMITH & NEPHEW, INC Decision Date To: 01/22/2020
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vaporized hydrogen peroxide (vhp) sterilization of uhmwpe components in the genesis knee system, the genesis ii knee sys SMITH & NEPHEW, INC. K012778 03/15/2002
tibial & patellar components for the profix & genesis ii total knee systems SMITH & NEPHEW, INC. K002740 11/30/2000
profix plus tibial insert, profix ps plus tibial insert, profix p/s tibial insert SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. K963255 01/02/1997
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