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6526
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15058
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11369
Dental
10143
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2836
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7889
General & Plastic Surgery
14247
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12365
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2661
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3173
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20
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4919
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3339
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3060
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16899
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894
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3156
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12966
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2667
Categories
GEX
Powered Laser Surgical Instrument
2442
LLZ
System, Image Processing,...
2077
GEI
Electrosurgical, Cutting &...
1952
DZE
Implant, Endosseous, Root-form
1334
HRS
Plate, Fixation, Bone
1292
GCJ
Laparoscope, General & Plastic...
1144
IYN
System, Imaging, Pulsed Doppler,...
1141
LZA
Polymer Patient Examination Glove
1104
LNH
System, Nuclear Magnetic...
1005
HWC
Screw, Fixation, Bone
992
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510k Database
Manufacturers
US
Unisplint Corp.
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Medical Device Manufacturer
·
US , Walker , MI
Unisplint Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1982
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unisplint Corp.
Dental
✕
1
devices
1-1 of 1
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Cleared
May 05, 1982
DENTAL ARCH BAR
K820944
·
DYX
Dental
·
29d
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2
Dental
1
General & Plastic Surgery
1