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535
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520
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489
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485
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431
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406
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400
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Manufacturers
US
Egnell, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Egnell, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
8 cleared
·
Since 1981
10
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Egnell, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 30, 1984
AMETHERM
K840526
·
FMZ
General Hospital
·
83d
Cleared
Apr 20, 1984
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
K834335
·
LBI
General Hospital
·
130d
Cleared
Dec 22, 1983
AMEDA NEONATAL RESUSCITATION UNIT-
K832637
·
FMT
General Hospital
·
140d
Cleared
Dec 02, 1981
PE-01 ELECTRONIC INFUSION PUMP
K812898
·
FRN
General Hospital
·
47d
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10
General & Plastic Surgery
5
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4
Obstetrics & Gynecology
1