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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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rosebud dissector Lorrex Health Products k945332 12/05/1994
rossmax non-invasive blood pressure monitors, models s380, k350 Rossmax International , Ltd. k052727 12/16/2005
rxsight insertion device Rxsight, Inc. k192926 01/17/2020
s500 seating system Fortress Scientific , Ltd. k933863 03/28/1994
safety insulin needle for single use Berpu Medical Technology Co., Ltd. k181447 03/12/2019
safetynet guidewire introducer Injectimed, Inc. k040029 04/05/2004
samboro latex patient examination gloves Ktp Gloves Industrial Corp. k891643 05/31/1989
scimed 6 french angiographic catheter modification Scimed Life Systems, Inc. k934541 05/12/1994
scintillant dual bent tip surgical light, scintillant dual straight tip surgical light Engineered Medical Solutions Co., LLC k133425 12/05/2013
seamless latex patient exam gloves Digitcare Corp. k920700 05/11/1992

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