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U.S. Department of Health and Human Services

510(k) Premarket Notification

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121 to 130 of 500 Results *
Decision Date To: 07/22/2019
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asahi ptca guide wire asahi gaia next Asahi Intecc Co., Ltd. K192599 01/02/2020
elos accurate customized abutment Elos Medtech Pinol A/S K192457 01/02/2020
oc-auto sensor io ifob test Eiken Chemical Co., Ltd. K191147 01/02/2020
optowire iii Opsens Inc. K191907 01/02/2020
air next NuvoAir AB K183089 01/02/2020
invacare aviva fx power wheelchair, model: ifx-20mp Invacare Corporation K192216 01/02/2020
optilume basic urological balloon dilation catheter Urotronic Inc K191061 01/02/2020
acuity sdr standard, acuity sdr plus, acuity fdr standard Radmedix LLC K193360 01/02/2020
incore tmt system Nextremity Solutions, Inc. K192578 12/31/2019
automistar Apollo Medical Imaging Technology Pty. Ltd. K192912 12/31/2019

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