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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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pf-2 battery operated electric four wheel power scooter IMC-HEARTWAY, LLC k031897 09/23/2003
ekf diagnostic hemo control hemoglobin measurement system EKF DIAGNOSTIC GMBH k031898 09/24/2003
quickvue influenza a+b test QUIDEL CORP. k031899 09/11/2003
handmaster NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS k031900 08/08/2003
proven revision femoral and proven revision tibial insert STELKAST COMPANY k031901 10/10/2003
online tdm carbamazepine ROCHE DIAGNOSTICS CORP. k031902 09/17/2003
rapido cut-away bleedback control valve (bbcv), model 7568 GUIDANT CORPORATION k031903 03/03/2004
digital clinical thermometer, models act2130, act 2230, act 2330, act 3136, and act 3030 ACTHERM, INC. k031905 07/07/2003
apeel cs catheter delivery system ST. JUDE MEDICAL k031906 07/18/2003
npac digital thermometer, models et 300, 301, 350, 351; et 400, 401, 450, 451; et 500, 501, 550, 551 NORM PACIFIC AUTOMATION CORP. k031907 08/21/2003

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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