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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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presep and pediasat oximetry catheters and vigileo arterial pressure cardiac output/oximetry monitor EDWARDS LIFESCIENCES, LLC. k053609 02/28/2006
precice stryde system NuVasive Specialized Orthopedics, Inc. k180503 04/03/2018
preat abutments Preat Corporation k183518 03/18/2019
pre-filled syringe & cystoflo urinary bg TRAVENOL LABORATORIES, S.A. k811924 11/10/1981
powdered natural rubber latex examination gloves (protein label claim) 200 micrograms or less of total water extractable MEDTEXX MANUFACTURING SDN. BHD. k070821 05/10/2007
powder-free vinyl patient examination gloves, white (non-colored) ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. k050154 02/07/2005
powder-free vinyl patient examination gloves SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD k073193 12/20/2007
powder-free vinyl patient examination gloves ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. k091663 07/27/2009
powder-free butadiene copolymer exam gloves with aloe, vitamins e ph5.5 SHEN WEI (USA), INC. k011961 09/26/2001
powder free vinyl patient examination gloves, light yellow color PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED k110972 06/06/2011

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