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963
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3579
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1582
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2214
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439
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2139
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3598
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3399
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353
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362
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15
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1148
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1617
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804
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472
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81
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694
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4150
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704
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LLZ
System, Image Processing,...
705
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610
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Electrosurgical, Cutting &...
521
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Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
392
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Prosthesis, Knee,...
350
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Thoracolumbosacral Pedicle Screw...
347
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Manufacturers
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Manufacturers
US
Sedatelec
Medical Device Manufacturer
·
US , Littleton , CO
Sedatelec - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1999
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sedatelec
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 26, 2006
ASP TITANIUM
K060392
·
MQX
General Hospital
·
70d
Cleared
Aug 27, 1999
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798
·
MQX
General Hospital
·
303d
Cleared
Aug 27, 1999
DN ACUPUNTURE NEEDLES
K983800
·
MQX
General Hospital
·
303d
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4
General Hospital
3
Physical Medicine
1