510k
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1069
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4350
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3247
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2790
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466
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2393
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4104
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3780
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800
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776
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1580
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System, Image Processing,...
725
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689
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568
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533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Aspen Labs
Medical Device Manufacturer
·
US , Utica , NY
Aspen Labs - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1991
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aspen Labs
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 30, 1997
HYFRECATOR 2000
K970493
·
GEI
General & Plastic Surgery
·
79d
Cleared
Mar 28, 1994
HAND-TROL S
K931215
·
DWG
General & Plastic Surgery
·
383d
Cleared
Mar 18, 1991
ELECTROSURGICAL UNIT WITH ACCESSORIES
K905654
·
GEI
General & Plastic Surgery
·
90d
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6
Obstetrics & Gynecology
3
General & Plastic Surgery
3