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1291
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1100
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1004
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992
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510k Database
Manufacturers
US
Ivion Corp.
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Medical Device Manufacturer
·
US , Broomfield , CO
Ivion Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1992
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ivion Corp.
General Hospital
✕
3
devices
1-3 of 3
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Cleared
Aug 16, 1993
TRILOGY INFUSION PUMP
K925311
·
FRN
General Hospital
·
299d
Cleared
Jul 27, 1993
IVION ADMIN SETS W/FLOW CLIPS
K925219
·
FPA
General Hospital
·
284d
Cleared
Nov 25, 1992
SURECATH PORT ACCESS CATHETER
K920036
·
LJT
General Hospital
·
324d
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3
General Hospital
3