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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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powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. k160675 08/02/2016
powder free latex patient examination gloves with aloe vera and protein content labeling claim of 50 micrograms or less MATANG MFG. SDN. BHD. k012558 09/17/2001
powder free (yellow) vinyl patient examination SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L k070044 01/29/2007
polymer coated, powder-free latex examination gloves with protein labeling (less than 50 ug/g per glove) SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. k040408 03/17/2004
polaris ds/comet SYNERON MEDICAL LTD. k041959 11/08/2004
pioneer tc8080, companion iii VIASYS NEURO CARE k053648 01/24/2006
pinpointe footlaser model 6w, 30w, 100w INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) k093545 10/15/2010
pinnacle3 smartarc PHILIPS MEDICAL SYSTEMS, INC. k090808 04/03/2009
piggyback venoset w/0.22 filter ABBOTT LABORATORIES k770518 04/29/1977
pico single use negative pressure wound therapy system, pico 7 single use negative pressure wound therapy system, pico 7y single use negative pressure wound therapy system, pico 14 single use negative pressure wound therapy system Smith and Nephew Medical Limited k203716 12/14/2021

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