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571
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1786
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394
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1447
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262
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1026
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2312
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2142
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133
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106
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483
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1033
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473
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3171
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2596
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159
Categories
LZA
Polymer Patient Examination Glove
428
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System, Image Processing,...
413
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Powered Laser Surgical Instrument
379
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Mask, Surgical
363
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Electrosurgical, Cutting &...
326
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System, Imaging, Pulsed Doppler,...
310
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Plate, Fixation, Bone
302
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Automated Radiological Image...
280
OLO
Orthopedic Stereotaxic Instrument
246
MAX
Intervertebral Fusion Device...
245
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Manufacturers
US
Precept, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Precept, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1976
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Precept, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 27, 1977
DISP. SURGICAL FACE MASK
K771409
·
FXX
General Hospital
·
87d
Cleared
Mar 23, 1977
MASK, SURGICAL, FACE, DISPOSABLE
K770463
·
FXX
General Hospital
·
14d
Cleared
Oct 20, 1976
SHIRT, MITTEN CUFF INFANT
K760360
·
FME
General Hospital
·
79d
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5
General Hospital
3
Anesthesiology
1
General & Plastic Surgery
1