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4327
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3210
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2780
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464
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2350
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775
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1404
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492
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725
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689
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558
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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
FR
Luneau SA
Medical Device Manufacturer
·
FR , Chartres Cedex
Luneau SA - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1985
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Luneau SA
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838
·
HKY
Ophthalmic
·
94d
Cleared
Sep 24, 2002
LUNEAU 3 MIRROR LENS
K022413
·
HJK
Ophthalmic
·
62d
Cleared
May 30, 1985
ANESTHESIOMETER
K851557
·
HJC
Ophthalmic
·
44d
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3
Ophthalmic
3