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511
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452
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387
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363
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351
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310
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286
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Manufacturers
US
Artsana S.P.A
Medical Device Manufacturer
·
US , Bristol , WI
Artsana S.P.A - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2005
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Artsana S.P.A
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 10, 2016
Safe Block Pen Needle
K151311
·
FMI
General Hospital
·
268d
Cleared
Nov 25, 2005
ARTSANA PISTON AND INSULIN SYRINGES
K052667
·
FMF
General Hospital
·
59d
Cleared
Oct 04, 2005
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
K051783
·
FMI
General Hospital
·
95d
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3
General Hospital
3