510k
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960
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3571
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1203
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2186
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404
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2102
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3524
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3371
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292
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259
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15
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1072
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1617
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771
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472
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6192
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81
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694
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4149
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644
Categories
LLZ
System, Image Processing,...
705
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Plate, Fixation, Bone
591
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Powered Laser Surgical Instrument
518
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Electrosurgical, Cutting &...
511
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
MAX
Intervertebral Fusion Device...
403
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Mask, Surgical
391
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Thoracolumbosacral Pedicle Screw...
347
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Prosthesis, Knee,...
346
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Manufacturers
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Manufacturers
US
Cpac, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Cpac, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1977
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cpac, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 20, 2011
STERI-DENT, STERI-SURE
K110867
·
FRG
General Hospital
·
113d
Cleared
Jul 12, 2011
STERI-DENT, STERI-SURE
K094026
·
KMH
General Hospital
·
559d
Cleared
Jul 14, 1977
DRY HEAT STERILIZER
K771070
·
KMH
General Hospital
·
30d
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5
General Hospital
3
General & Plastic Surgery
1
Dental
1