FDA 510(k) Applications Submitted by Da Kyung Ham

FDA 510(k) Number Submission Date Device Name Applicant
K210122 01/19/2021 Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) Osteonic Co., Ltd.
K231322 05/08/2023 Fix2Lock(PEEK Self Punching) Osteonic Co., Ltd.
K231326 05/08/2023 Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) Osteonic Co., Ltd.
K202763 09/21/2020 Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd.
K202806 09/23/2020 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) OSTEONIC Co., Ltd.
K071134 04/23/2007 SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM SONOSITE,INC.
K092058 07/08/2009 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC.
K052109 08/04/2005 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) SONOSITE,INC.
K053069 11/01/2005 SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) SONOSITE,INC.
K043452 12/15/2004 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM SONOSITE,INC.
K043559 12/27/2004 SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) SONOSITE,INC.
K202663 09/14/2020 Suture Wing Osteonic Co., Ltd.
K200659 03/12/2020 Dermalux Tri-Wave MD Aesthetic Technology Ltd.
K212275 07/20/2021 Dermalux Flex MD Aesthetic Technology Ltd.
K202028 07/22/2020 dermalux Flex MD Aesthetic Technology Ltd
K990863 03/16/1999 MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE ROSS PRODUCT DIV. ABBOTT LABORATORIES
K031407 05/05/2003 ROSS EMBRACE ENTERAL PUMP ROSS PRODUCT DIV. ABBOTT LABORATORIES
K011467 05/14/2001 ROSS EMBRACE PUMP SET ROSS PRODUCTS
K972437 06/30/1997 ROSS ENTERAL FEEDING TUBE ROSS PRODUCTS
K962554 07/01/1996 FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE ABBOTT LABORATORIES
K992494 07/26/1999 FLEXIFLO ENTERAL FEEDING TUBE ROSS PRODUCT DIV. ABBOTT LABORATORIES
K963113 08/12/1996 FLEXIFLO POLYG GASTOSTOMY TUBE ABBOTT LABORATORIES
K980187 01/20/1998 MLT R694 RUBY LASER SYSTEM MEDICAL LASER TECHNOLOGIES LTD.
K990902 03/18/1999 MODIFICATION OF MLT R694 RUBY LASER SYSTEM MEDICAL LASER TECHNOLOGIES LTD.
K121108 04/12/2012 DOPPLEX ABILITY HUNTLEIGH HEALTHCARE
K091591 06/02/2009 FLEXICARE MEDICAL ENDOTRACHEAL TUBES FLEXICARE MEDICAL LTD.
K092218 07/22/2009 FLEXICARE BREATHING FILTERS FLEXICARE MEDICAL LTD.
K122330 08/02/2012 FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE ARJOHUNTLEIGH POLSKA SP Z.O.O.
K133119 09/30/2013 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS ARJOHUNTLEIGH POLSKA SP Z.O.O.


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