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Powered Laser Surgical Instrument
2444
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2086
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1961
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1335
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1294
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1146
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System, Imaging, Pulsed Doppler,...
1143
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Polymer Patient Examination Glove
1104
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System, Nuclear Magnetic...
1007
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Screw, Fixation, Bone
993
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510k Database
Manufacturers
MY
Straitscom
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Medical Device Manufacturer
·
MY , Penang Perai
Straitscom - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1989
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Straitscom
General Hospital
✕
3
devices
1-3 of 3
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Cleared
Jan 24, 1991
HYPOALLERGENIC LATEX EXAMINATION GLOVES
K910009
·
LYY
General Hospital
·
22d
Cleared
Aug 17, 1990
SURGEON'S (SURGICAL) GLOVES
K903534
·
KGO
General Hospital
·
11d
Cleared
Sep 13, 1989
NON-STERILE EXAM GLOVES
K885319
·
LYY
General Hospital
·
258d
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3
General Hospital
3