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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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abuscreen(r) ontrak(tm) for cocaine Roche Diagnostic Systems, Inc. k881815 07/29/1988
cobas(r)-fp reagents for gentamicin and cobas(r)-fp gentamicin calibrators Roche Diagnostic Systems, Inc. k945523 03/09/1995
blue powder free nitrile examination glove with grape scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220672 06/03/2022
diode laser device (rf3120-bi) Risu Medical Technology Co., Ltd. k251329 06/27/2025
rionet &/or rion hearing aid mod. hb-67s Rion Acoustic Instruments, Inc. k800738 04/24/1980
revive reusable bladder support Rinovum Subsidiary 2, LLC k183468 01/25/2019
opti-fix collared femoral components Richards Medical Co., Inc. k874868 01/26/1988
femoral canal brush Richard'S Medical Equip., Inc. k810267 02/09/1981
respironics' digital manometer Respironics, Inc. k904935 04/03/1991
coil field extender Resonex, Inc. k911800 07/03/1991

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