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671
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533
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519
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489
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431
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
386
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Manufacturers
FI
Wallac OY
Medical Device Manufacturer
·
FI , Finland
Wallac OY - FDA 510(k) Cleared Devices
22 submissions
·
21 cleared
·
Since 1992
22
Total
21
Cleared
1
Denied
FDA 510(k) Regulatory Record - Wallac OY
Toxicology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 09, 1994
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490
·
CGI
Toxicology
·
87d
Cleared
Dec 17, 1992
DELFIA DIGOXIN KIT
K924594
·
KXT
Toxicology
·
98d
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22
Chemistry
18
Toxicology
2
Pathology
1
Hematology
1