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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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icu medical needle, lopez needle Icu Medical, Inc. k860781 05/06/1986
icon reader Hybritech, Inc. k862956 08/19/1986
hydro2, hs-75 Innovision, Inc. k000485 05/12/2000
hunter scientific injection pipettes Hunter Scientific Limited k001615 08/18/2000
human igg subclass liquid reagent kits (for use on hitachi 911/ 912/ 917 and modular p) The Binding Site, Ltd. k090920 12/30/2009
hudson rci® comfort flo nasal cannula; hudson rci® comfort flo plus cannula Medline Industries, LP k240163 09/27/2024
hoya illumina (sorafilcon a) daily disposable soft contact lens, hoya illumina (sorafilcon a) toric daily disposable soft contact lens, hoya illumina (sorafilcon a) multifocal daily disposable soft contact lens Hoya Lamphun , Ltd. k223397 01/03/2024
hot shot Schiff Photo Mechanics k833233 10/28/1983
hg pro xp nitrile powder free examination gloves tested for use with chemotherapy drugs Healthy Glove Co., Ltd. k162381 01/31/2017
heliosit Vivadent (Usa), Inc. k802683 11/24/1980

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