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3651
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9911
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8626
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6119
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1983
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5228
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8287
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6705
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1997
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2556
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16
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4825
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2945
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1871
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1461
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12427
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635
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1600
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8277
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2154
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1400
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1179
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1136
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944
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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
696
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510k Database
Manufacturers
US
Optacryl, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Optacryl, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1981
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optacryl, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
May 05, 1982
OPTACRY/95 BLUE CONTACT LENS BLANKS
K820815
·
HPX
Ophthalmic
·
42d
Cleared
May 05, 1982
OPTACRY/ 95 GREEN CONTACT LENS BLANKS
K820816
·
HPX
Ophthalmic
·
42d
Cleared
May 05, 1982
OPTACRY/95 GRAY CONTACT LENS BLANKS
K820817
·
HPX
Ophthalmic
·
42d
Cleared
Jun 11, 1981
OPTOCRYL CONTACT LENS BLANKS
K810130
·
HPX
Ophthalmic
·
143d
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4
Ophthalmic
4