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1132
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210
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1891
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125
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Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
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Polymer Patient Examination Glove
278
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Electrosurgical, Cutting &...
260
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Automated Radiological Image...
256
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System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
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Orthopedic Stereotaxic Instrument
204
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Abutment, Implant, Dental,...
191
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Intervertebral Fusion Device...
171
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P.T. Latexindo Tobaperkasa
Medical Device Manufacturer
·
ID , Medan
P.T. Latexindo Tobaperkasa - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - P.T. Latexindo Tobaperkasa
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 05, 1998
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K974443
·
LYZ
General Hospital
·
41d
Cleared
Nov 18, 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539
·
LYY
General Hospital
·
133d
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3
General Hospital
2
Orthopedic
1