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533
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519
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Polymer Patient Examination Glove
489
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461
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Intervertebral Fusion Device...
403
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400
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Screw, Fixation, Bone
392
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Manufacturers
US
Stan-Pak Ent.
Medical Device Manufacturer
·
US , Mchenry , IL
Stan-Pak Ent. - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 1982
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stan-Pak Ent.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 05, 1982
BIAS STOCKINETTE
K820141
·
FQM
General Hospital
·
17d
Cleared
Feb 05, 1982
TUBULAR STOCKINETTE
K820142
·
FQM
General Hospital
·
17d
Cleared
Jan 29, 1982
ELASTIC BANDAGE
K820094
·
FQM
General Hospital
·
16d
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20
General & Plastic Surgery
13
General Hospital
3
Physical Medicine
2
Anesthesiology
1
Pathology
1