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532
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1643
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359
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1318
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242
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955
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2169
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2036
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126
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97
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462
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952
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433
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2828
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52
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515
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2403
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Polymer Patient Examination Glove
407
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381
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358
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351
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299
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
209
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Shenzhenshi Sincoheren S&T Development Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhenshi Sincoheren S&T Development Co., Ltd. - FDA 510(k) Cleared...
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhenshi Sincoheren S&T Development Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 19, 2023
Radio Frequency System
K231749
·
GEI
General & Plastic Surgery
·
126d
Cleared
Sep 20, 2023
LED Spectrum therapy instrument
K231894
·
GEX
General & Plastic Surgery
·
84d
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General & Plastic Surgery
2