510k
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483
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1461
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339
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1159
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215
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849
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1915
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1455
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125
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90
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8
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432
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364
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242
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2513
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49
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443
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2081
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147
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Powered Laser Surgical Instrument
313
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System, Image Processing,...
307
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Polymer Patient Examination Glove
282
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Electrosurgical, Cutting &...
263
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Automated Radiological Image...
257
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Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
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Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Bio Quantum Technologies, Inc.
Medical Device Manufacturer
·
US , Parker , CO
Bio Quantum Technologies, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
5 cleared
·
Since 1983
6
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio Quantum Technologies, Inc.
Radiology
✕
1
devices
1-1 of 1
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Cleared
Mar 11, 1983
MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM
K837110
Radiology
·
63d
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6
General & Plastic Surgery
3
Obstetrics & Gynecology
1
Radiology
1
Gastroenterology & Urology
1