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1415
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5350
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4303
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3153
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530
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2828
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4561
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4147
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1074
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1228
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15
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2404
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1995
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991
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546
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8334
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347
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996
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5405
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1339
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LLZ
System, Image Processing,...
777
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Plate, Fixation, Bone
698
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System, Imaging, Pulsed Doppler,...
632
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Electrosurgical, Cutting &...
620
GEX
Powered Laser Surgical Instrument
528
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
490
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
451
NKB
Thoracolumbosacral Pedicle Screw...
443
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Search FDA 510(k) devices
510k Database
Manufacturers
US
California Ent.
Medical Device Manufacturer
·
US , Sun Valley , CA
California Ent. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1988
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - California Ent.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 04, 1988
DAEWOO LATEX SURGICAL GLOVE
K880035
·
KGO
General Hospital
·
59d
Cleared
Feb 16, 1988
DISPOSABLE SYRINGE
K875097
·
FMF
General Hospital
·
68d
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General Hospital
2