510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
General Hospital
2038
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126
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97
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8
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462
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958
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433
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274
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2828
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52
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515
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2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Shandong Shengshixincheng Medical Science & Technology Co.,
Medical Device Manufacturer
·
CN , Binzhou
Shandong Shengshixincheng Medical Science & Technology Co., - FDA 510...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shandong Shengshixincheng Medical Science & Technology Co.,
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 10, 2021
Disposable Vinyl Examination Gloves
K210522
·
LYZ
General Hospital
·
107d
Cleared
May 26, 2021
Disposable Synthetic Examination Gloves
K210520
·
LYZ
General Hospital
·
92d
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General Hospital
2