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1380
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5299
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3959
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2897
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516
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2666
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4420
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4007
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985
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1070
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15
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2119
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1975
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980
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541
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8275
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201
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978
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5403
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1325
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777
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696
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632
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601
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Powered Laser Surgical Instrument
528
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
GB
Racom, Inc.
Medical Device Manufacturer
·
GB , Rg7 4lp, Berkshire
Racom, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1989
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Racom, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 13, 1990
LIFE-TEL CELLULAR TRANSCEIVER
K900541
·
DXH
Cardiovascular
·
158d
Cleared
Jul 27, 1989
IMEX RHYTHM TEK
K890114
·
DSH
Cardiovascular
·
197d
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Cardiovascular
2