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510k Database
Manufacturers
US
Envisioneering, LLC
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Medical Device Manufacturer
·
US , St. Louis , MO
Envisioneering, LLC - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2004
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Envisioneering, LLC
Radiology
✕
4
devices
1-4 of 4
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Cleared
Dec 21, 2007
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
K073399
·
FCG
Radiology
·
17d
Cleared
Sep 02, 2004
TARGETSCAN BIOPSY KIT
K041638
·
ITX
Radiology
·
77d
Cleared
Sep 02, 2004
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
K041639
·
IYO
Radiology
·
77d
Cleared
Sep 01, 2004
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
K041637
·
ITX
Radiology
·
76d
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4
Radiology
4