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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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scimed 6 french angiographic catheter modification Scimed Life Systems, Inc. k934541 05/12/1994
samboro latex patient examination gloves Ktp Gloves Industrial Corp. k891643 05/31/1989
safetynet guidewire introducer Injectimed, Inc. k040029 04/05/2004
safety insulin needle for single use Berpu Medical Technology Co., Ltd. k181447 03/12/2019
s500 seating system Fortress Scientific , Ltd. k933863 03/28/1994
rxsight insertion device Rxsight, Inc. k192926 01/17/2020
rossmax non-invasive blood pressure monitors, models s380, k350 Rossmax International , Ltd. k052727 12/16/2005
rosebud dissector Lorrex Health Products k945332 12/05/1994
rmi vascular tourniquet kit Research Medical, Inc. k910221 05/16/1991
rionet &/or rion hearing aid mod. hb-67s Rion Acoustic Instruments, Inc. k800738 04/24/1980

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