510k
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333
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1068
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270
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809
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148
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628
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1322
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760
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99
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72
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366
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582
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244
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155
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2055
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40
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310
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1585
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132
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Powered Laser Surgical Instrument
229
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211
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System, Imaging, Pulsed Doppler,...
208
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206
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
169
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Abutment, Implant, Dental,...
158
MAX
Intervertebral Fusion Device...
138
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Thoracolumbosacral Pedicle Screw...
135
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Lerner Laboratories, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Lerner Laboratories, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1976
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lerner Laboratories, Inc.
Pathology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 22, 1985
XYLENE SUBSTITUTE
K853694
·
KEM
Pathology
·
48d
Cleared
Oct 22, 1985
XYLENE SUBSTITUTE MONTANT
K854083
·
KEM
Pathology
·
15d
Cleared
Dec 06, 1976
PAP-TRAY I (CATALOG #C600-1)
K761000
·
LEA
Pathology
·
28d
Cleared
Dec 06, 1976
PAP-TRAY II (CATALOG #C600-2)
K761001
·
LEA
Pathology
·
28d
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5
Pathology
4
Chemistry
1