510k
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538
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1656
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360
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1323
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244
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957
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2176
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2039
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126
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97
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8
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462
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959
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433
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274
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2844
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52
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515
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2413
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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 &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Dongguan Shin YI Healthcare Products Factory
Medical Device Manufacturer
·
CN , Dong Guan
Dongguan Shin YI Healthcare Products Factory - FDA 510(k) Cleared Dev...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dongguan Shin YI Healthcare Products Factory
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610
·
FYA
General Hospital
·
170d
Cleared
Jun 07, 2021
Disposable Surgical Mask
K210372
·
FXX
General Hospital
·
119d
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General Hospital
2