FDA 510(k) Applications Submitted by ROBERT HILL

FDA 510(k) Number Submission Date Device Name Applicant
K120110 01/13/2012 ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET PROFIT POINT MANUFACTURING SDN BHD
K140355 02/12/2014 SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM TERANG NUSA SDN BHD
K110698 02/17/2011 NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD
K130450 02/22/2013 SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE PURNA BINA SDN BHD
K170779 03/15/2017 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein Terang Nusa Sdn Bhd
K150973 04/13/2015 NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs TERANG NUSA SND BHD
K151392 05/26/2015 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less TERANG NUSA SDN BHD
K131751 06/14/2013 FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES LUCENXIA PRESCIENCE AG
K151607 06/15/2015 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG
K151605 06/15/2015 Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves Lucenxia Prescience AG
K101760 06/23/2010 ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES PROFIT POINT MANUFACTURING SDN BHD
K171987 07/03/2017 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG
K161932 07/14/2016 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink Terang Nusa Sdn Bhd
K102119 07/28/2010 SUR-G GLOV AND MAXITEX TERANG NUSA SDN BHD
K102230 08/09/2010 NUGARD NITILE GREY COLOR TERANG NUSA SDN BHD
K162852 10/11/2016 Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG
K173304 10/18/2017 Finessis Intense Polyisoprene Surgical Glove Lucenxia Prescience Ag
K173386 10/30/2017 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs Lucenxia Prescience AG
K083337 11/12/2008 NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES TERANG NUSA SDN BHD
K123628 11/23/2012 STERILE LATEX SURGICAL GLOVE LUCENXIA PRESCIENCE AG
K123629 11/23/2012 FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES LUCENXIA PRESCIENCE AG
K083571 12/03/2008 ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR PURNABINA SDN BHD
K153510 12/07/2015 Powder Free Polychloroprene Examination Glove Green TERANG NUSA SDN BHD
K972847 08/01/1997 KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) EASTMAN KODAK COMPANY
K060175 01/23/2006 ISIGHT IMAGING CATHETER, MODEL 38986 BOSTON SCIENTIFIC CORP.
K090403 02/17/2009 AUTOSPECT PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K050684 03/17/2005 ATLANTIS PV BOSTON SCIENTIFIC CORP.
K040776 03/26/2004 ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 BOSTON SCIENTIFIC CORP.
K060947 04/06/2006 SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP.
K051679 06/23/2005 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP.
K041727 06/25/2004 MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC SCIMED, INC.
K041818 07/06/2004 SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP.
K063312 11/02/2006 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 BOSTON SCIENTIFIC CORP.


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