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3922
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926
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881
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790
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757
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730
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697
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582
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Polymer Patient Examination Glove
555
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Intervertebral Fusion Device...
539
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510k Database
Manufacturers
DK
Oticon A/S
Medical Device Manufacturer
·
DK , Thisted
Oticon A/S - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1995
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oticon A/S
Ear, Nose, Throat
✕
2
devices
1-2 of 2
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Cleared
Mar 18, 2014
TINNITUS SOUNDSUPPORT
K133308
·
KLW
Ear, Nose, Throat
·
141d
Cleared
Sep 18, 1995
AMENDMENTS TO MULTIFOCUS
K951002
·
ESD
Ear, Nose, Throat
·
203d
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Ear, Nose, Throat
2