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3640
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9905
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8609
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6104
Ear, Nose, Throat
1979
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5224
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8286
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6698
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1996
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2553
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16
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4822
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2942
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1869
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1458
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12409
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635
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1597
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8269
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2144
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Powered Laser Surgical Instrument
1400
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1179
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1136
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944
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System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
794
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Prosthesis, Knee,...
788
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Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
708
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Implant, Endosseous, Root-form
693
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510k Database
Manufacturers
US
Skatron, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Skatron, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1981
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skatron, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 22, 1982
96 WELL DISPENSER
K821961
·
JTC
Microbiology
·
21d
Cleared
May 03, 1982
MICROPLATE WASHING DEVICE
K820992
·
JTC
Microbiology
·
25d
Cleared
Oct 26, 1981
IMMUNOASSAY PLATE
K812860
·
JTC
Microbiology
·
13d
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4
Microbiology
3
Chemistry
1