허가이력 | LK Consulting Group

LK CONSULTING GROUP

ABOUT US

다음은 당사가 진행하여 510k 허가를 완료한 제품 코드 목록입니다. 최신 허가 제품 품목은 업데이트가 안 되어있을 수도 있으니, 목록에서 찾지 못하실 경우 당사로 연락주시면 추가 안내해드리도록 하겠습니다. 510k 외에 다른 프로젝트들은 (시설등록 및 제품 리스팅, DMF, 테스트 진행 등) 허가 이력이 아님에 아래에 열거되지 않았습니다. 또한 이 리스트는 총 프로젝트 진행 수는 아니며 동일 제품 코드를 10건 이상 진행한 케이스들도 있습니다.

Product Code	Device Common Name
EIH	Dental Frame Material for Dental Prosthesis & Liquid Stain for Dental Zirconium Prosthesis
GEI	Radiofrequency System
ELW	Dental Impression Material
LLZ	Radiological Imaging Software
LQY	Apex Locator
GEX	Medical Laser System
NBW, CGA ,JJX	Blood Glucose Test System Quality control material (assayed and unassayed)
EBF	Light-cured Flowable Restorative Material
MQB	Digital Flat Panel X-ray Detector
NKB	Pedicle Screw Spinal Fixation System
NDN, HRX	Inflatable Bone Tamp
NUH	Transcutaneous Electrical Nerve Stimulator
LCP	Test System for Hemoglobin A1c
EBZ	Dental curing light
ILY	Infrared Lamp
DZE, NHA	Endosseous dental implant system
EBW	Dental Handpiece and Accessories
GCJ	Tissue Bags
HET	Gynecologic laparoscope and accessories
GCJ	Sterile Trocars for Endoscopic surgery
GWO, GXR, HBW	Neuro Plating System
JEY	Dental Bone Plates and Screws
EFB	Air-powered dental handpieces
LLZ	Medical LCD Monitor
FMI	Hypodermic Single Lumen Needle
NDD, HRX	Inflatable Bone Tamp
EKX	Dental Handpiece and Accessories
DYW	Orthodontic bracket
OAS	Dental Computed Tomography X-ray System
KWP	Interspinous Process Fixation System
NBW, CHH, JGY, LBR	Blood Glucose Monitoring System Cholesterol Monitoring System
DRG, DXN, NBW, FRI	Healthcare Data Management Mobile Application
MIB	Elastomer, Silicone Block
MUI	ULTRASOUND GEL PAD
GXN, GXR	Cranioplasty Plate Fastener
BSO	Anesthesia conduction catheter
GEI	Electrosurgical accessory
HRX	Arthroscope
KIF	Root Canal Filling Material Root Canal Sealing Material
NBW, JQP	Data Management Software
CHH, JGY, LBR	Cholesterol Monitoring System
FYD	Air-handling apparatus for a surgical operating room
DZB	Headgear, Extraoral, Orthodontic
DZL	Screw, Fixation, Intraosseous
EBC	Sealant, Pit and Fissure, and Conditioner
EBG	Crown and Bridge, Temporary, Resin
EBI	Resin, Denture, Relining, Repairing, Rebasing
EIA	Unit, Operative Dental
EMA	Cement, Dental
FCG	Needle, Biopsy
FLL	Continuous Measurement Thermometer
FMF	Syringe, Piston
FRG	Sterilization Wrap
FWP	Prosthesis, Chin, Internal
FXX	Mask, Surgical
FYA	Gown, Surgical
FZE	Prosthesis, Nose, Internal
HGX	Pump, Breast, Powered
HXG	Tamp (Orthopedic Manual Surgical Instrument)
JFB	Multi-Function Physical Therapy Table
JJE	Test, Glycosylated Hemoglobin
JSM	Culture Media, Non-Propagating Transport
KKY	Prosthesis, PTFE/Carbon-Fiber
KLE	Agent, Tooth Bonding, Resin
KPR	System, X-Ray, Stationary
KTI	Bronchoscope (Flexible or Rigid) and Accessories
LBH	Varnish, Cavity
LFR	System, Test, Blood Glucose, Over The Counter
LZK	Implant, Malar
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar
MEG	Syringe, Antistick
MIC	Implant, Muscle, Pectoralis
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle Fixation
MUE	Full Field Digital Mammographic X-Ray System
MUH	System, X-Ray, Extraoral Source, Digital
MVL	Cord, Retraction
NBL	Laser, Fluorescence Caries Detection
NHJ	Device, Positive Pressure Breathing, Intermittent
NPK	Barrier, Synthetic, Dental
OCX	Endoscopic Irrigation/Suction System
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
ONG	Powered Laser Surgical Instrument With Microbeam/Fractional Output
OUH	Skin Resurfacing RF Applicator
OZC	over the counter thermal treatment for acne
PGY	Display, Diagnostic Radiology
PLL	Endoscope and Accessories (Submucosal Injection Agent)
QFM	Radiological Computer-Assisted Prioritization Software For Lesions
QIH	Radiological Computer-Assisted Triage And Notification Software