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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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ptw dosimetry diode, t60008 PTW-NEW YORK CORP. k010916 06/20/2001
power tilt and recline system SUNRISE MEDICAL, INC. k010917 05/15/2001
lifepak 12 defibrillator/monitor system MEDTRONIC PHYSIO-CONTROL CORP. k010918 08/23/2001
male natural rubber latex condom INNOLATEX SDN. BHD k010919 06/15/2001
transducers for fetal ultrasonic and tokodynamometer monitoring MEDICAL CABLES, INC. k010920 06/22/2001
advantage marijuana (thc) home drug test ADVANTAGE DIAGNOSTICS CORP. k010921 06/25/2001
tri-fix spinal fixation system ENDIUS, INC. k010922 06/06/2001
kion anaesthesia system, model 65 03 879 e392e SIEMENS ELEMA AB k010923 01/23/2002
modification to plum xl infusion pump ABBOTT LABORATORIES k010924 04/06/2001
servoi ventilator system, model 64 87 800 e407e SIEMENS ELEMA AB k010925 12/18/2001

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