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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
Sort by PMA Number [0-9]
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510(K)
Number
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Decision
Date
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angioskip Siemens Corp. k781991 12/07/1978
siemens polydoros 800 Siemens Corp. k820112 02/24/1982
hem ave-toxo screening hemagglutination test kit Si Sero-Immuno Diagnostics, Inc. k851976 10/16/1985
shiley cricothyrotomy tube Shiley, Inc. k781639 10/24/1978
ipl hair removal, model: w-1095, w-1098 Shenzhen Wochuan Electronic Co., Ltd. k232124 09/14/2023
disposable nitrile examination gloves Shenzhen Shiqiao Science and Technology Co., Ltd. k211264 07/30/2021
ipl sapphire ice cooling hair remove device Shenzhen Desida Technology Co., Ltd. k221635 08/31/2022
powder-free vinyl examination gloves Shen Wei (Usa), Inc. k033693 01/16/2004
flexible ureterorenoscope (us27f-12-eu; us27f-12-us) Shanghai AnQing Medical Instrument Co., Ltd. k243857 04/11/2025
burn bath Setma, Inc. k841397 05/18/1984

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