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Ear, Nose, Throat
2016
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947
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818
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795
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788
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740
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724
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510k Database
Manufacturers
US
Optus, Inc.
Medical Device Manufacturer
·
US , Denver , CO
Optus, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1994
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optus, Inc.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 02, 1996
OPTUS OTOSCOPES
K945264
·
ERA
Ear, Nose, Throat
·
462d
Cleared
Dec 21, 1995
OPTUS BRONCHOSCOPES
K945268
·
EOQ
Ear, Nose, Throat
·
419d
Cleared
Jan 26, 1995
OPTUS SINUSCOPES AND ACCESSORIES
K944656
·
EOB
Ear, Nose, Throat
·
127d
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10
Ear, Nose, Throat
3
Orthopedic
2
General & Plastic Surgery
2
Obstetrics & Gynecology
1
Gastroenterology & Urology
1
Anesthesiology
1