510k
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540
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1660
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362
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1329
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244
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957
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2182
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2039
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126
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97
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8
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464
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962
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433
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274
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2862
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52
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515
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2418
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
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System, Imaging, Pulsed Doppler,...
288
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Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Skypro Medical Supplies Company
Medical Device Manufacturer
·
CN , Hong Kong
Skypro Medical Supplies Company - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skypro Medical Supplies Company
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 12, 2023
Skypro, Surgical Gown 6021
K230707
·
FYA
General Hospital
·
212d
Cleared
Dec 24, 2021
Skypro, SP02 Mask (3)
K202255
·
FXX
General Hospital
·
501d
Cleared
Aug 26, 2016
Skypro, SP01 Mask
K152197
·
FXX
General Hospital
·
387d
Filters
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3
General Hospital
3