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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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model bt-220l and bt-220c Bistos Co., Ltd. k142799 07/09/2015
modification to health buddy appliance HEALTH HERO NETWORK, INC. k070543 03/28/2007
modification to philips avalon fetal monitors fm20 and fm30 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH k062137 08/24/2006
modification to: playtex gentle glide plastic, playtex gentle plastic multipack tampons PLAYTEX PRODUCTS, INC. k070745 04/13/2007
modification to: ultralon (r) powder free latex surgical gloves ANSELL HEALTHCARE PRODUCTS, INC. k013604 11/13/2001
molli 2 MOLLI Surgical, Inc. k231579 10/26/2023
monarc sling system AMERICAN MEDICAL SYSTEMS, INC. k023516 11/19/2002
movation knee system ENCORE MEDICAL, L.P. k121727 08/15/2012
mr810 system, 900mr810 adult single limb circuit, 900mr810e adult dual limb circuit Fisher & Paykel Healthcare Ltd k143646 03/05/2015
mri tobramycin ria kit MICROANALYTIC RESEARCH, INC. k813516 12/29/1981

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