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15032
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11361
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10129
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2832
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7874
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14234
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Categories
GEX
Powered Laser Surgical Instrument
2438
LLZ
System, Image Processing,...
2075
GEI
Electrosurgical, Cutting &...
1949
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Implant, Endosseous, Root-form
1333
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Plate, Fixation, Bone
1291
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Laparoscope, General & Plastic...
1143
IYN
System, Imaging, Pulsed Doppler,...
1139
LZA
Polymer Patient Examination Glove
1098
LNH
System, Nuclear Magnetic...
1004
HWC
Screw, Fixation, Bone
992
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510k Database
Manufacturers
US
Berkley and Co.
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Medical Device Manufacturer
·
US , Mchenry , IL
Berkley and Co. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1984
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Berkley and Co.
Dental
✕
2
devices
1-2 of 2
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Cleared
Dec 03, 1984
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE
K843171
·
DZC
Dental
·
112d
Cleared
Jan 24, 1984
FILAFEX ESTHETIC ORTHODINIC WIRE
K833788
·
DZC
Dental
·
85d
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3
Dental
2
General & Plastic Surgery
1