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701
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510
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483
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476
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427
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403
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391
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345
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343
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Manufacturers
US
Lumitex, Inc.
Medical Device Manufacturer
·
US , Cleveland , OH
Lumitex, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1991
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lumitex, Inc.
General Hospital
✕
2
devices
1-2 of 2
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Cleared
Jun 08, 2012
GIRAFFE BLUE SPOT PT LITE
K120820
·
LBI
General Hospital
·
81d
Cleared
Apr 17, 2006
BILISOFT PHOTOTHERAPY SYSTEM
K053568
·
LBI
General Hospital
·
116d
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3
General Hospital
2
Ophthalmic
1