510k
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Anesthesiology
540
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1660
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362
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1323
Ear, Nose, Throat
244
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957
General & Plastic Surgery
2179
General Hospital
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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960
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433
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274
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2846
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52
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515
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2417
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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
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Guangzhou Zhengkang Medical Equipment Co.,Ltd
Medical Device Manufacturer
·
CN , Guangzhou
Guangzhou Zhengkang Medical Equipment Co.,Ltd - FDA 510(k) Cleared De...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangzhou Zhengkang Medical Equipment Co.,Ltd
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 23, 2022
Medical Surgical Mask
K222204
·
FXX
General Hospital
·
60d
Cleared
Nov 05, 2021
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
K212460
·
FXX
General Hospital
·
92d
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2
General Hospital
2