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2874
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2287
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2281
Latex Patient Examination Glove
LYY
1954
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1534
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1430
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1325
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1286
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1182
Polymer Patient Examination Glove
LZA
1181
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Empi
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Medical Device Manufacturer
·
US , Walker , MI
Empi - FDA 510(k) Cleared Devices
60 submissions
·
56 cleared
·
Since 1977
View 60 510(k) Devices ↓
Official Website
60
Total
56
Cleared
0
Denied
29
devices
26-29 of 29
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1
2
Cleared
May 14, 1980
EMPI MODEL 910S, TENS
K801112
·
GZJ
Neurology
·
2d
Cleared
Mar 17, 1980
FES ORTHOSIS MODEL NO. 2000
K800380
·
GZI
Neurology
·
24d
Cleared
Dec 13, 1979
MODEL 980D TENS NEUROPACER
K792522
·
GZJ
Neurology
·
7d
Cleared
Nov 02, 1977
IMPORTED PAIN CONTROL DEVICE
K771885
·
GZJ
Neurology
·
28d
1
2
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60
Neurology
29
Physical Medicine
20
Gastroenterology & Urology
10
General & Plastic Surgery
1