FDA 510(k) Applications Submitted by PRISCILLA JUHEE CHUNG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120020 |
01/03/2012 |
VIVIX-S |
VIEWORKS CO., LTD. |
| K140037 |
01/07/2014 |
OPTIMUS CMF SYSTEM |
OSTEONIC CO., LTD. |
| K140052 |
01/09/2014 |
J2I IMPLANT SYSTEM |
KJ MEDITECH CO., LTD. |
| K140051 |
01/09/2014 |
KJ EXTERNAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD. |
| K120089 |
01/11/2012 |
BIOGENESIS IMPLANT SYSTEM |
BIOGENESIS CO., LTD. |
| K130181 |
01/25/2013 |
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K130221 |
01/29/2013 |
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM |
MEDIMECCA CO., LTD. |
| K120353 |
02/06/2012 |
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM |
BM KOREA CO., LTD. |
| K130295 |
02/06/2013 |
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. |
INFOPIA CO., LTD |
| K140432 |
02/20/2014 |
HI-LIGHT, HI-LIGHT PLUS |
DENTALL CORPORATION |
| K130657 |
03/12/2013 |
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE |
ALL MEDICUS CO., LTD |
| K130694 |
03/14/2013 |
JR IMPLANT SYSTEM |
LK Consulting Group USA, Inc. |
| K150747 |
03/23/2015 |
EzDent-i /E2/Prora View |
LK Consulting Group USA, Inc. |
| K121047 |
04/06/2012 |
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD |
| K121098 |
04/11/2012 |
HERO I DENTAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD |
| K140976 |
04/16/2014 |
ENADEN FLOW |
KM CORPORATION |
| K091157 |
04/21/2009 |
GLUCO LAB AUTO CODING, MODEL IGM-0022 |
INFOPIA CO., LTD |
| K131117 |
04/22/2013 |
ZIRMON SERIES |
KUWOTECH CO., LTD |
| K141046 |
04/23/2014 |
MIDI-SRS |
SRMC CO., LTD |
| K111169 |
04/26/2011 |
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF |
KWANG MYUNG DAICOM INC |
| K111312 |
05/10/2011 |
SANTEVIEW |
SEHYUN CO., LTD. |
| K111341 |
05/12/2011 |
CLEANE / CLEANE POP |
MEDICON CO., LTD. |
| K141452 |
06/02/2014 |
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW |
JEIL MEDICAL CORPORATION |
| K141482 |
06/04/2014 |
KI-20 |
SAEYANG MICROTECH CO LTD |
| K111573 |
06/06/2011 |
MONOBLOC BM SERIES |
HASS CORP. |
| K131682 |
06/10/2013 |
UD IMPLANT SYSTEM |
MEDIMECCA CO., LTD. |
| K131905 |
06/26/2013 |
SOLID GEL PAD |
BLUEMTECH |
| K111820 |
06/28/2011 |
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE |
BM KOREA CO., LTD. |
| K141750 |
06/30/2014 |
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM |
INFOPIA CO., LTD |
| K101875 |
07/06/2010 |
BK BLANK MODEL 20,40,65,90 |
BK MEDENT CO., LTD. |
| K132123 |
07/10/2013 |
TRC-PEX, RADIC-SEALER |
KM CORPORATION |
| K141861 |
07/10/2014 |
HILTHERA 4.0 |
JEISYS MEDICAL, INC. |
| K132144 |
07/11/2013 |
KERATOR |
LK Consulting Group USA, Inc. |
| K132148 |
07/11/2013 |
S HEALTH |
SAMSUNG ELECTRONICS CO., LTD. |
| K141886 |
07/14/2014 |
MDK HANDPIECES |
MODERN KOREA CO., LTD. |
| K141891 |
07/14/2014 |
MEDICAL LCD MONITOR |
KOSTEC CO., LTD |
| K141911 |
07/15/2014 |
OPTIMUS NEURO SYSTEM |
OSTEONIC CO., LTD. |
| K112078 |
07/21/2011 |
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) |
MARUCHI |
| K132302 |
07/24/2013 |
QXLINK |
VIEWORKS CO., LTD. |
| K132406 |
08/02/2013 |
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K102223 |
08/06/2010 |
CHALLENGE-EVER |
HALLIM DENTECH CO., LTD. |
| K102305 |
08/16/2010 |
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P |
HASS CORP. |
| K122518 |
08/17/2012 |
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE |
BM KOREA CO., LTD. |
| K102575 |
09/08/2010 |
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) |
DO CO., LTD. |
| K132825 |
09/09/2013 |
RETROMTA-ORTHOMTA II |
BIOMTA |
| K132862 |
09/12/2013 |
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K122866 |
09/18/2012 |
VIVIX-S WITH VXVUE |
VIEWORKS CO., LTD. |
| K122865 |
09/18/2012 |
VIVIX-S WIRELESS |
VIEWORKS CO., LTD. |
| K132966 |
09/20/2013 |
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K123016 |
09/27/2012 |
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS |
MICOBIOMED CO, LTD |
| K123007 |
09/27/2012 |
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM |
MICOBIOMED CO, LTD |
| K133042 |
09/27/2013 |
ENDOCEM ZR |
MARUCHI |
| K133050 |
09/27/2013 |
ONE PLUS IMPLANT SYSTEM |
OSSEOFUSE, INC. |
| K133054 |
09/27/2013 |
ENDOSEAL |
MARUCHI |
| K103019 |
10/12/2010 |
KJ MASK |
KJ MEDITECH CO., LTD |
| K103021 |
10/12/2010 |
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K133260 |
10/23/2013 |
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
| K123332 |
10/26/2012 |
NAOMI-CT |
LK CONSULTING GROUP |
| K113192 |
10/31/2011 |
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K173541 |
11/15/2017 |
EPINAUT |
Imedicom Co., Ltd. |
| K133669 |
11/29/2013 |
MEDINAUT KYPHOPLASTY SYSTEM |
IMEDICOM |
| K113549 |
12/01/2011 |
COMFORT COUGH |
SEOIL PACIFIC CORP. |
| K133716 |
12/05/2013 |
TRC-PASTE |
KM CORPORATION |
| K223660 |
12/06/2022 |
SaintView |
Inviz Corporation |
| K113670 |
12/13/2011 |
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
| K103810 |
12/29/2010 |
KJ SUBMERGED SYSTEM |
KJ MEDITECH CO., LTD |
| K090405 |
02/19/2009 |
LIPIDPRO SYSTEM |
INFOPIA CO., LTD |
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