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3594
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8590
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6022
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1962
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5212
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6662
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1996
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2552
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16
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1597
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1363
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1168
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1135
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935
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818
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System, Imaging, Pulsed Doppler,...
794
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Prosthesis, Knee,...
787
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740
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708
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Implant, Endosseous, Root-form
676
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510k Database
Manufacturers
US
Medi-Spec
Medical Device Manufacturer
·
US , Mchenry , IL
Medi-Spec - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1978
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medi-Spec
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 26, 1981
WHISK-R
K812694
·
GEE
General & Plastic Surgery
·
34d
Cleared
Apr 24, 1980
MEDSPEC OPERATIVE OPTHALMIC KIT
K800404
·
HMP
General & Plastic Surgery
·
58d
Cleared
Jun 05, 1979
CLAMP COVERS
K790952
·
GAD
General & Plastic Surgery
·
14d
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8
General & Plastic Surgery
3
General Hospital
2
Obstetrics & Gynecology
2
Ophthalmic
1