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Manufacturers
US
Optonol, Ltd.
Medical Device Manufacturer
·
US , Rockville , MD
Optonol, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2002
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optonol, Ltd.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 13, 2003
EXPRESS MINI GLAUCOMA SHUNT
K030350
·
KYF
Ophthalmic
·
38d
Cleared
Mar 26, 2002
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
K012852
·
KYF
Ophthalmic
·
214d
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2
Ophthalmic
2