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557
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3110
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Polymer Patient Examination Glove
424
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407
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371
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361
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318
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
301
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
241
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Intervertebral Fusion Device...
237
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Manufacturers
US
Spirotech, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Spirotech, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1983
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spirotech, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 26, 1984
SPIROTECH ST-550
K840972
·
BZG
Anesthesiology
·
112d
Cleared
Jun 03, 1983
SPIROTECH ST-5500
K823770
·
BZG
Anesthesiology
·
171d
Cleared
Jan 28, 1983
SPIROTECH 300
K823771
·
BTY
Anesthesiology
·
45d
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3
Anesthesiology
3