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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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510(K)
Number
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Decision
Date
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skingard polycoat glove Top Quality Mfg., Inc. k004018 05/11/2001
smartflow, model sfip 2000 Florence Medical , Ltd. k003122 05/14/2001
somas human spinal fluid control Somas Medical Industries, Inc. k840974 04/05/1984
sonoline elegra diagnostic ultrasound system Siemens Medical Solutions USA, Inc. k003125 10/20/2000
sopheia cortisol eia kit Diagnostic Products Corp. k822845 10/27/1982
spacer-s temporary shoulder spacer Tecres S.P.A. k060535 05/24/2006
sperm wash medium, cat# 2003/2005 Invitrocare, Inc. k000989 06/08/2000
spiral radius rodding system United States Surgical, A Division of Tyco Healthc k000009 03/10/2000
splittable sheath introducer kit Thomas Medical Products, Inc. k004025 07/19/2001
spo2 sensor css032d Shenzhen Ykd Technology Co., Ltd. k251751 12/19/2025

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