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5416
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4586
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3251
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540
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2869
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4726
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4194
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1088
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356
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800
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699
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695
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633
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537
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524
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System, Nuclear Magnetic...
499
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Polymer Patient Examination Glove
490
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Intervertebral Fusion Device...
465
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Thoracolumbosacral Pedicle Screw...
448
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510k Database
Manufacturers
US
Fisons Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Fisons Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1977
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fisons Corp.
Anesthesiology
✕
2
devices
1-2 of 2
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Cleared
Jan 27, 1995
FISONEB(R) II
K950206
·
CAF
Anesthesiology
·
9d
Cleared
Aug 29, 1985
SYNCHRONER TM (PROPOSED TRADENAME)
K853350
·
CCQ
Anesthesiology
·
17d
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3
Anesthesiology
2
General Hospital
1