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14950
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11326
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10053
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2821
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7814
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14134
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12205
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2650
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3154
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20
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5978
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4861
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3283
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3009
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Categories
GEX
Powered Laser Surgical Instrument
2412
LLZ
System, Image Processing,...
2051
GEI
Electrosurgical, Cutting &...
1931
DZE
Implant, Endosseous, Root-form
1328
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Plate, Fixation, Bone
1285
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Laparoscope, General & Plastic...
1135
IYN
System, Imaging, Pulsed Doppler,...
1134
LZA
Polymer Patient Examination Glove
1081
LNH
System, Nuclear Magnetic...
999
HWC
Screw, Fixation, Bone
987
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510k Database
Manufacturers
MY
Smart Glove Corp. Sdn Bhd
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Medical Device Manufacturer
·
MY , Klang Selangor
Smart Glove Corp. Sdn Bhd - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 1998
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Mar 13, 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870
·
LYY
General Hospital
·
74d
Cleared
Mar 13, 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907
·
LZA
General Hospital
·
72d
1
2
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27
General Hospital
27