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332
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1061
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269
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805
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148
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622
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1321
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752
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98
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72
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1
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365
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574
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244
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155
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2050
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40
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309
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1581
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132
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Powered Laser Surgical Instrument
228
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210
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System, Imaging, Pulsed Doppler,...
208
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205
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
168
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Abutment, Implant, Dental,...
156
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Intervertebral Fusion Device...
137
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Thoracolumbosacral Pedicle Screw...
135
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Lkb Instruments, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Lkb Instruments, Inc. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1976
52
Total
52
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lkb Instruments, Inc.
Pathology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 05, 1987
LKB 2260 MACROTOME
K864733
·
IDO
Pathology
·
32d
Cleared
Nov 30, 1984
LKB 2230 ROTARY ONE
K843505
·
IDO
Pathology
·
85d
Cleared
Nov 30, 1984
LKB 2189 ULTROPROCESSOR
K843506
·
IEO
Pathology
·
85d
Filters
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All
52
Chemistry
31
Anesthesiology
5
Hematology
4
Pathology
3
Toxicology
3
Microbiology
2
General Hospital
1
Radiology
1
Immunology
1
Cardiovascular
1