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3771
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10066
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8804
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6178
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2016
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5359
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8496
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2048
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2624
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16
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4947
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1899
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1481
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639
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1637
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8417
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2194
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1449
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1193
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1152
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947
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System, Nuclear Magnetic...
818
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795
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Prosthesis, Knee,...
788
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Hearing Aid, Air-conduction,...
740
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724
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Implant, Endosseous, Root-form
699
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Search FDA 510(k) devices
510k Database
Manufacturers
NL
Polyganics B.V.,
Medical Device Manufacturer
·
NL , Groningen
Polyganics B.V., - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2003
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Polyganics B.V.,
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 20, 2011
NEUROLAC(R) NERVE GUIDE
K112267
·
JXI
Neurology
·
73d
Cleared
May 04, 2005
NEUROLAC NERVE GUIDE
K050573
·
JXI
Neurology
·
58d
Cleared
Oct 10, 2003
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
K032115
·
JXI
Neurology
·
93d
Filters
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9
Ear, Nose, Throat
5
Neurology
3
General & Plastic Surgery
1