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1092
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4436
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3276
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2794
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4114
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3832
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805
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167
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963
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730
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690
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568
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
520
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Prosthesis, Knee,...
493
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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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Mask, Surgical
400
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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 Hospital
✕
2
devices
1-2 of 2
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Cleared
Mar 12, 1980
STERILE DRESSING PACK
K800490
·
KKX
General Hospital
·
8d
Cleared
Aug 21, 1978
DISPOSA-LOOPS
K780548
·
KKX
General Hospital
·
138d
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8
General & Plastic Surgery
3
General Hospital
2
Obstetrics & Gynecology
2
Ophthalmic
1