510k
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4339
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3233
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2789
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465
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2379
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4094
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3734
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789
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776
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15
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1580
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1755
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876
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495
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7543
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165
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963
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4605
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1238
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System, Image Processing,...
725
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689
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568
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
JP
Erica Optical Co.
Medical Device Manufacturer
·
JP , Sakai Gun, Fukui-Pref
Erica Optical Co. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1994
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Erica Optical Co.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
May 31, 1996
SUNGLASSES
K961146
·
HQY
Ophthalmic
·
71d
Cleared
Jul 12, 1994
FRAME, SPECTACLE
K942463
·
HQZ
Ophthalmic
·
49d
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2
Ophthalmic
2