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11373
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10150
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2837
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7894
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14264
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894
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12981
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GEX
Powered Laser Surgical Instrument
2442
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System, Image Processing,...
2079
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Electrosurgical, Cutting &...
1954
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1334
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Plate, Fixation, Bone
1293
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Laparoscope, General & Plastic...
1146
IYN
System, Imaging, Pulsed Doppler,...
1142
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Polymer Patient Examination Glove
1104
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System, Nuclear Magnetic...
1006
HWC
Screw, Fixation, Bone
992
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510k Database
Manufacturers
US
Pennwalt Corp.
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Medical Device Manufacturer
·
US , Mchenry , IL
Pennwalt Corp. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1978
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pennwalt Corp.
Radiology
✕
3
devices
1-3 of 3
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Cleared
Oct 28, 1983
INTREX
K833241
·
EAP
Radiology
·
67d
Cleared
Mar 03, 1980
XR-710
K800063
·
EAP
Radiology
·
52d
Cleared
Mar 03, 1980
PANOREX II DENTAL X-RAY UNIT
K800133
·
EHD
Radiology
·
42d
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6
Radiology
3
Dental
2
Anesthesiology
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