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4502
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3346
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2794
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469
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2444
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4116
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796
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1737
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497
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730
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696
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568
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535
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521
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502
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
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Intervertebral Fusion Device...
406
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400
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Manufacturers
US
Sharpoint, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Sharpoint, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1982
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sharpoint, Inc.
Ophthalmic
✕
5
devices
1-5 of 5
Filters
Cleared
May 09, 1984
CORNEAL SCLERAL LANCE
K840855
·
HNN
Ophthalmic
·
75d
Cleared
Mar 16, 1984
ANTERIOR CAPSULECTOMY CYSTITOME
K840659
·
HNY
Ophthalmic
·
30d
Cleared
Mar 16, 1984
POSTERIOR CAPSULOTOMY CYSTITOME
K840660
·
HNY
Ophthalmic
·
30d
Cleared
Aug 10, 1982
OPHTHALMIC KNIFE
K822112
·
HNN
Ophthalmic
·
22d
Cleared
Jun 14, 1982
V LANCE
K821440
·
HNN
Ophthalmic
·
32d
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9
Ophthalmic
5
General & Plastic Surgery
3
Ear, Nose, Throat
1