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GEX
Powered Laser Surgical Instrument
2368
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System, Image Processing,...
1988
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1868
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1282
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1257
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1112
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1098
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Polymer Patient Examination Glove
1048
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System, Nuclear Magnetic...
982
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Screw, Fixation, Bone
972
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Manufacturers
HK
Swank Plus , Ltd.
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Medical Device Manufacturer
·
HK , Hong Kong
Swank Plus , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1988
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Swank Plus , Ltd.
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 01, 1988
FRAME, SPECTACLE
K873965
·
HQZ
Ophthalmic
·
185d
Cleared
Feb 26, 1988
SUNGLASSES (NONPRESCRIPTION)
K873966
·
HQY
Ophthalmic
·
150d
Cleared
Feb 26, 1988
SPECTACLE, MAGNIFYING
K873967
·
HOT
Ophthalmic
·
150d
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3
Ophthalmic
3