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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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orthocad software option ESAOTE, S.P.A. k120288 09/19/2012
espree' breathing circuit (w/access ESP PLASTICS, INC. k821311 05/21/1982
ultracision harmonic scalpel coagulating shears, model lcsc5,lcsc1,cs23c,cs231,cs14c,cs141,lcsb5,lcsk5,lcs15,lcs16,cs150 ETHICON ENDO-SURGERY, INC. k002981 04/09/2001
euroimmun ana ifa: hep-20-10 EUROIMMUN US LLC k070763 05/22/2007
ever-more powder-free polymer-coated latex examination gloves EVER-MORE LATEX PRODUCTS SDN BHD k023523 11/29/2002
optecure EXACTECH, INC. k050806 02/08/2006
the visual speech aid EXETER MEDICAL LABS, INC. k781522 11/08/1978
clinical alert notification EXTENSION , INC k130339 07/11/2013
extrapure reverse osmosis water unit EXTRACORPOREAL MEDICAL SPECIALITIES, INC. k822385 10/13/1982
sodium/potassium conditioning reagent FISHER SCIENTIFIC CO., LLC. k800216 02/26/1980

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