510k
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557
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1746
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388
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1418
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258
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1011
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2114
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478
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1001
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462
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293
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3129
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52
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522
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2538
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Categories
LZA
Polymer Patient Examination Glove
424
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System, Image Processing,...
408
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Powered Laser Surgical Instrument
372
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361
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Electrosurgical, Cutting &...
320
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
302
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Automated Radiological Image...
278
MAX
Intervertebral Fusion Device...
242
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Orthopedic Stereotaxic Instrument
241
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Manufacturers
US
Imm Enterprises , Ltd.
Medical Device Manufacturer
·
US , Walker , MI
Imm Enterprises , Ltd. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1983
52
Total
52
Cleared
0
Denied
FDA 510(k) Regulatory Record - Imm Enterprises , Ltd.
✕
1
devices
1-1 of 1
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Cleared
Apr 23, 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305
·
DWS
Cardiovascular
·
90d
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52
General & Plastic Surgery
25
Gastroenterology & Urology
5
Obstetrics & Gynecology
4
Ear, Nose, Throat
4
Neurology
3
Anesthesiology
3
Dental
2
Ophthalmic
2
Hematology
1
General Hospital
1