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3958
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2897
Ear, Nose, Throat
515
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2657
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4403
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984
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978
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768
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696
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631
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597
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527
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522
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Polymer Patient Examination Glove
489
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485
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Ensoniq Corp.
Medical Device Manufacturer
·
US , Malvern , PA
Ensoniq Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1989
Official Website
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ensoniq Corp.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
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Cleared
Jan 24, 1994
SOUND SELECTOR FULL-SERVICE AUDIOMETER
K933097
·
EWO
Ear, Nose, Throat
·
214d
Cleared
Jan 13, 1989
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
K882633
·
ESD
Ear, Nose, Throat
·
200d
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Ear, Nose, Throat
2