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4938
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3696
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2821
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476
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2526
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758
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696
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609
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576
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Powered Laser Surgical Instrument
526
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522
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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Manufacturers
US
Kab Gloves Unltd.
Medical Device Manufacturer
·
US , Berkley , MI
Kab Gloves Unltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kab Gloves Unltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
May 07, 1990
CU-75 VISIBLE LIGHT-CURING UNIT
K900135
·
EBZ
Dental
·
117d
Cleared
Apr 04, 1990
SALIVA ABSORBER - DENTAL
K900631
·
DYN
Dental
·
55d
Cleared
Apr 03, 1990
FG DIAMOND BURRS
K900089
·
DZP
Dental
·
88d
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4
Dental
3
General Hospital
1