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689
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535
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520
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489
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468
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431
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404
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400
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Manufacturers
US
Lukens Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Lukens Corp. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1977
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lukens Corp.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 11, 1977
TRAY, CATHETERIZATION W/FOLEY, STERILE
K770797
·
FRG
General Hospital
·
70d
Cleared
Jun 22, 1977
SKIN SCRUB PREP SET
K770796
·
KKX
General Hospital
·
51d
Cleared
Jun 22, 1977
TRAY, IRRIGATION, STERILE, BASIC
K770799
·
KKX
General Hospital
·
51d
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11
General & Plastic Surgery
6
General Hospital
3
Physical Medicine
1
Chemistry
1