FDA 510(k) Applications Submitted by Y B Cho

FDA 510(k) Number Submission Date Device Name Applicant
K221523 05/26/2022 Tanning Lamp Unilam Co., Ltd.
K160060 01/12/2016 DMi Dental Implant System DMi Innovative Medical Technology Ltd.
K173198 10/02/2017 Facet Screw Fixation System U&i Corporation
K242111 07/19/2024 VIVACE Unimom.Co
K093145 10/05/2009 SPECTRA SERIES BREAST PUMP UZINMEDICARE CO.
K200639 03/10/2020 LAP-iX Sejong Medical Co., Ltd.
K200638 03/10/2020 LAP-iX Suction Irrigation Sejong Medical Co., Ltd.
K171741 06/12/2017 Laport Sejong Medical Co., Ltd.
K171726 06/12/2017 LapBag Sejong Medical Co., Ltd.
K173112 09/29/2017 LAP-iX Sejong Medical Co., Ltd.
K173108 09/29/2017 Smoklean Sejong Medical Co., Ltd.
K173111 09/29/2017 LAP-iX Suction Irrigation Sejong Medical Co., Ltd.
K203337 11/12/2020 PainTB, PainTJ Ptech Co., Ltd.
K242857 09/20/2024 ClearHemograsper Finemedix Co., Ltd.
K051925 07/18/2005 CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN ACCESS BIO INCORPORATE
K031048 04/02/2003 CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE
K031052 04/02/2003 CARESTART HCG ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE
K032159 07/15/2003 CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY ACCESS BIO INCORPORATE
K143043 10/22/2014 Tanning Lamp UNILAM CO., LTD.
K180347 02/08/2018 3d Cage Fims Co., Ltd.
K221969 07/05/2022 IU Implant System Abutment Warantec Co., Ltd,
K221972 07/05/2022 Warantec Custom Abutment Warantec Co., Ltd,
K012135 07/09/2001 POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) WRP ASIA PACIFIC SDN. BHD.
K020019 01/03/2002 POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) WRP ASIA PACIFIC SDN. BHD.
K010072 01/09/2001 POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE WRP ASIA PACIFIC SDN. BHD.
K960178 01/16/1996 COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) WEMBLEY RUBBER PRODUCTS (M) SDN BHD
K960407 01/29/1996 COMFIT ORTHOPEDIC WEMBLEY RUBBER PRODUCTS (M) SDN BHD
K960416 01/29/1996 COMFIT MICROPTIC WEMBLEY RUBBER PRODUCTS (M) SDN BHD
K000971 03/27/2000 PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE WRP ASIA PACIFIC SDN. BHD.
K001280 04/21/2000 COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES WRP ASIA PACIFIC SDN. BHD.
K011482 05/14/2001 DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) WRP ASIA PACIFIC SDN. BHD.
K021784 05/30/2002 PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) WRP ASIA PACIFIC SDN. BHD.
K012048 06/29/2001 POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE WRP ASIA PACIFIC SDN. BHD.
K002064 07/07/2000 COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL WRP ASIA PACIFIC SDN. BHD.
K022444 07/25/2002 POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA WRP ASIA PACIFIC SDN. BHD.
K022442 07/25/2002 POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) WRP ASIA PACIFIC SDN. BHD.
K022904 09/03/2002 DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD.
K003019 09/27/2000 PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE WRP ASIA PACIFIC SDN. BHD.
K993313 10/04/1999 COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE WRP ASIA PACIFIC SDN. BHD.
K993311 10/04/1999 COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE WRP ASIA PACIFIC SDN. BHD.
K023490 10/16/2002 DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL WRP ASIA PACIFIC SDN. BHD.
K003653 11/27/2000 STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) WRP ASIA PACIFIC SDN. BHD.
K001613 05/25/2000 COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) WRP ASIA PACIFIC SDN. BHD.
K002827 09/11/2000 MAC ACUPUNCTURE NEEDLE HAENGLIM SEOWON CORP.
K220625 03/03/2022 ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System REMED Co., Ltd


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