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1352
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5022
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3888
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2896
Ear, Nose, Throat
488
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2598
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4306
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3995
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983
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936
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15
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1963
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1924
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914
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507
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8244
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188
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978
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5349
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1325
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768
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696
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631
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582
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Powered Laser Surgical Instrument
527
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522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Rockwin Corp.
Medical Device Manufacturer
·
US , Dekalb , IL
Rockwin Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rockwin Corp.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129
·
ESD
Ear, Nose, Throat
·
39d
Cleared
May 24, 1995
RIONET HM-02
K943808
·
ESD
Ear, Nose, Throat
·
293d
Cleared
Jan 27, 1994
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
K935559
·
ESD
Ear, Nose, Throat
·
71d
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3
Ear, Nose, Throat
3