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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
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510(K)
Number
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Decision
Date
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hemosorb ON SITE GAS SYSTEMS, INC. k021581 07/12/2002
hemophron RENAL DEVICES, INC. k810612 04/29/1981
hemocath MED-CONDUIT, INC. k043292 03/16/2005
hemicap patello-femoral resurfacing system ARTHROSURFACE, INC. k071413 11/09/2007
hearing aid model f8h anl f8t WIDEX HEARING AID CO., INC. k770688 04/20/1977
health-plus, sanitex, reliance, powder-free latex examination gloves PWA INDUSTRIES SDN. BHD. k001485 06/13/2000
headstar medical small volume jet nebulizer HEADSTAR MEDICAL PRODUCTS CO., LTD k121770 04/17/2013
handx instrument - monopolar spatula Human Xtensions Ltd. k222011 01/12/2023
hammer toe implant TRILLIANT SURGICAL LTD k122959 11/07/2012
great glove powder free vinyl examination gloves GREAT GLOVE (CHINA), INC. k052923 12/21/2005

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