510k
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Specialties
Anesthesiology
3666
Cardiovascular
9925
Chemistry
8638
Dental
6125
Ear, Nose, Throat
1987
Gastroenterology & Urology
5237
General & Plastic Surgery
8303
General Hospital
6707
Hematology
1998
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2558
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16
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4830
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2949
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1877
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1463
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12430
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635
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1600
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8280
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2169
Categories
GEX
Powered Laser Surgical Instrument
1400
GEI
Electrosurgical, Cutting &...
1179
LLZ
System, Image Processing,...
1136
HRS
Plate, Fixation, Bone
944
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
794
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
720
DZE
Implant, Endosseous, Root-form
699
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510k Database
Manufacturers
US
Edu Kit , Ltd.
Medical Device Manufacturer
·
US , Walker , MI
Edu Kit , Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1982
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edu Kit , Ltd.
Neurology
✕
1
devices
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Cleared
Feb 18, 1982
TNS MK I STIMULATOR
K812612
·
GZJ
Neurology
·
156d
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Neurology
1