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643
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633
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620
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544
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497
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496
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492
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510k Database
Manufacturers
US
Fresenius USA, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Fresenius USA, Inc. - FDA 510(k) Cleared Devices
38 submissions
·
37 cleared
·
Since 1984
38
Total
37
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fresenius USA, Inc.
Dental
✕
2
devices
1-2 of 2
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Cleared
Jul 01, 1993
FRESENIUS PD+ EXCHANGE DEVICE
K915634
·
EKX
Dental
·
562d
Cleared
Apr 15, 1988
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106
·
LFD
Dental
·
189d
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38
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4
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