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520
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493
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489
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431
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406
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400
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Manufacturers
KR
Bontech, Inc.
Medical Device Manufacturer
·
KR , Suwon-Si
Bontech, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bontech, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485
·
MQB
Radiology
·
30d
Cleared
Oct 14, 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487
·
MQB
Radiology
·
37d
Cleared
Jun 09, 2016
BSD4343 Digital Flat Panel X-ray Detector
K160204
·
MQB
Radiology
·
133d
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Radiology
3