510k
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2075
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458
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302
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1181
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2596
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2358
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142
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127
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569
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1173
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532
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354
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3698
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57
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566
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2934
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483
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Polymer Patient Examination Glove
444
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426
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386
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376
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System, Imaging, Pulsed Doppler,...
358
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344
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Intervertebral Fusion Device...
294
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285
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Orthopedic Stereotaxic Instrument
280
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Manufacturers
US
Carol Cole Company
Medical Device Manufacturer
·
US , La Jolla , CA
Carol Cole Company - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2007
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carol Cole Company
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 30, 2016
NuFACE Gel Primer
K161654
·
GYB
Neurology
·
198d
Cleared
Apr 17, 2014
NUFACE MINI DEVICE
K133823
·
NFO
Neurology
·
121d
Cleared
Oct 01, 2013
TRINITY ELE
K131251
·
NFO
Neurology
·
153d
Cleared
Nov 07, 2011
NUFACE PLUS
K103472
·
NFO
Neurology
·
348d
Cleared
Nov 27, 2007
NUFACE, MODEL NU-4003
K072260
·
NFO
Neurology
·
105d
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6
Neurology
5
General & Plastic Surgery
1