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510k Database
Manufacturers
KR
Bontech Co., Ltd.
Medical Device Manufacturer
·
KR , Suwon-Si
Bontech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
Recent clearances:
BONX805
,
BSD3543W
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bontech Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 12, 2025
BONX805
K243864
·
IZL
Radiology
·
269d
Cleared
Apr 23, 2020
BSD3543W
K200787
·
MQB
Radiology
·
28d
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Radiology
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