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510
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485
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483
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435
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403
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391
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345
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343
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Manufacturers
US
P/L Biomedical
Medical Device Manufacturer
·
US , Fort Myers , FL
P/L Biomedical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - P/L Biomedical
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 25, 2012
CLICKFINE PEN NEEDLE
K122969
·
FMI
General Hospital
·
29d
Cleared
Oct 25, 2012
CLICKFINE PEN NEEDLE
K122971
·
FMI
General Hospital
·
29d
Cleared
Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135
·
FPA
General Hospital
·
81d
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3
General Hospital
3