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Manufacturers
KR
I-Sens, Inc.
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Medical Device Manufacturer
·
KR , Seoul
I-Sens, Inc. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 2008
28
Total
28
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468
·
NBW
Chemistry
·
78d
Cleared
Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923
·
NBW
Chemistry
·
198d
1
2
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28
Chemistry
27
General & Plastic Surgery
1