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1989
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944
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818
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794
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788
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740
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721
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699
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510k Database
Manufacturers
US
Gentex Corporation
Medical Device Manufacturer
·
US , Mchenry , IL
Gentex Corporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1977
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gentex Corporation
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 12, 1980
THE LENS OR OMMI-GARD
K800521
·
HQG
Ophthalmic
·
6d
Cleared
Nov 09, 1977
RX LENS SERIES
K772024
·
HQG
Ophthalmic
·
14d
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3
Ophthalmic
2
General Hospital
1