510k
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560
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1756
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388
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259
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462
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3133
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2544
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LZA
Polymer Patient Examination Glove
425
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System, Image Processing,...
409
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373
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361
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321
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System, Imaging, Pulsed Doppler,...
308
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Plate, Fixation, Bone
302
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Automated Radiological Image...
279
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Intervertebral Fusion Device...
242
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Orthopedic Stereotaxic Instrument
241
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Manufacturers
US
Khi, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Khi, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1980
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Khi, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 17, 1983
RAD VALVE
K830404
·
BTL
Anesthesiology
·
38d
Cleared
Mar 10, 1983
COUPLING/VALVE
K830399
·
BTC
Anesthesiology
·
31d
Cleared
Jul 16, 1981
KHI CPRAM BREATHING CIRCUIT
K811858
·
CAI
Anesthesiology
·
15d
Cleared
Mar 18, 1980
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
K800456
·
BTL
Anesthesiology
·
18d
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4
Anesthesiology
4