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8533
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12203
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3649
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9571
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Categories
Powered Laser Surgical Instrument
GEX
2874
System, Image Processing, Radiological
LLZ
2287
Electrosurgical, Cutting &...
GEI
2281
Latex Patient Examination Glove
LYY
1954
Implant, Endosseous, Root-form
DZE
1534
Laparoscope, General & Plastic Surgery
GCJ
1430
Plate, Fixation, Bone
HRS
1325
Hearing Aid, Air-conduction,...
ESD
1286
System, Imaging, Pulsed Doppler,...
IYN
1182
Polymer Patient Examination Glove
LZA
1181
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510k Database
Manufacturers
US
Empire Plastics Manufacturer
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Medical Device Manufacturer
·
US , Mchenry , IL
Empire Plastics Manufacturer - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1979
View 4 510(k) Devices ↓
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Empire Plastics Manufacturer
Anesthesiology
✕
4
devices
1-4 of 4
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Cleared
Dec 31, 1979
ALARM USED W/MONITORING SPIROMETER
K792573
·
BZK
Anesthesiology
·
18d
Cleared
Dec 19, 1979
COUNTER UNIT
K792571
·
BWF
Anesthesiology
·
6d
Cleared
Dec 19, 1979
EMPIRE SPIROMETER
K792572
·
BZK
Anesthesiology
·
6d
Cleared
Apr 27, 1979
LUNG FUNCTION AMPLIFIER EXERCISER
K790744
·
BWF
Anesthesiology
·
11d
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4
Anesthesiology
4