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1355
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5036
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3958
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2897
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516
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2657
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4415
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4000
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985
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1052
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15
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2049
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1930
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946
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541
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8263
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201
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978
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5352
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1325
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768
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696
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631
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601
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Powered Laser Surgical Instrument
527
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Prosthesis, Knee,...
522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
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
Cooper Lasersonics, Inc.
Medical Device Manufacturer
·
US , Orangeburg , NY
Cooper Lasersonics, Inc. - FDA 510(k) Cleared Devices
54 submissions
·
52 cleared
·
Since 1982
Official Website
54
Total
52
Cleared
0
Denied
54
devices
51-54 of 54
Filters
1
2
3
Cleared
Dec 21, 1983
MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000
K833480
·
LNK
Gastroenterology & Urology
·
89d
Cleared
Mar 03, 1983
ULTRASCAN DIGITAL A/SYSTEM III
K828328
Radiology
·
78d
Cleared
Sep 13, 1982
NIIC CO2 LASER SYSTEM MODEL 6OZ.
K827913
Radiology
·
31d
Cleared
Sep 13, 1982
NIIC CO2 LASER SYSTEM MODEL 3OZ.
K827914
Radiology
·
31d
1
2
3
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54
General & Plastic Surgery
19
Gastroenterology & Urology
12
Ophthalmic
4
Obstetrics & Gynecology
4
Ear, Nose, Throat
4
Anesthesiology
3
Radiology
3
Neurology
3
Dental
1
Cardiovascular
1