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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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fiesta imaging option GE MEDICAL SYSTEMS k002997 04/11/2001
nonabsorbable polypropylene surgical suture TYCO HEALTHCARE GROUP, LP k010909 04/09/2001
health-plus, sanitex, reliance multiply powder free polymer and nitrile coated (blue) PAMITEX INDUSTRIES SDN BHD k003350 04/05/2001
exacta-mix 2400 compounding system, model exacta-mix 2400 BAXA CORP. k002705 03/28/2001
fogarty valvulotome, model 700091 EDWARDS LIFESCIENCES, LLC. k001734 03/26/2001
aosept plus cleaning and disinfecting solution CIBA VISION CORPORATION k003345 03/26/2001
whittlestone breastpump WHITTLESTONE, INC. k002696 03/21/2001
pm 1800 conserving device PRECISION MEDICAL, INC. k001412 03/20/2001
escreen system ESCREEN, INC. k003352 03/20/2001
npac multi-use thermometer, model td400 NORM PACIFIC AUTOMATION CORP. k010224 03/18/2001

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