510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1333
Ear, Nose, Throat
244
Gastroenterology & Urology
958
General & Plastic Surgery
2183
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2868
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52
Physical Medicine
515
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2428
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Shandong Shengquan New Material Co., Ltd.
Medical Device Manufacturer
·
CN , Jinan
Shandong Shengquan New Material Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shandong Shengquan New Material Co., Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 10, 2021
Child Face Mask
K201514
·
OXZ
General Hospital
·
489d
Cleared
Dec 14, 2020
Medical Face Mask
K201629
·
FXX
General Hospital
·
181d
Cleared
Sep 04, 2020
Protective Face Mask for Medical Use
K201537
·
FXX
General Hospital
·
88d
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3
General Hospital
3