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Powered Laser Surgical Instrument
2442
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2077
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1951
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1334
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1292
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Laparoscope, General & Plastic...
1144
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System, Imaging, Pulsed Doppler,...
1141
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Polymer Patient Examination Glove
1104
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System, Nuclear Magnetic...
1005
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Screw, Fixation, Bone
992
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510k Database
Manufacturers
Ansell Intl.
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Medical Device Manufacturer
·
MT , Melaka
Ansell Intl. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ansell Intl.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 21, 1993
NUTEX GLOVES
K920745
·
KGO
General Hospital
·
349d
Cleared
Feb 06, 1991
SENSIDERM
K904244
·
KGO
General Hospital
·
145d
Cleared
Jan 28, 1991
SENSITOUCH
K904769
·
KGO
General Hospital
·
98d
Cleared
Mar 09, 1990
ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
K895781
·
LZC
General Hospital
·
163d
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4
General Hospital
4