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533
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519
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489
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464
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403
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400
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392
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Manufacturers
HK
Nam Tai , Ltd.
Medical Device Manufacturer
·
HK , Kowloon, Hong Kong
Nam Tai , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1985
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nam Tai , Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 27, 1987
FORTEC MI-306, MI-327 DIGITAL THERMOMETER
K872584
·
FLL
General Hospital
·
26d
Cleared
Jan 27, 1986
FORTEC MI-305 & 306 DIGITAL THERMOMETER
K853317
·
FLL
General Hospital
·
173d
Cleared
May 13, 1985
FORTEC MI-305
K851873
·
FLL
General Hospital
·
14d
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4
General Hospital
3
Cardiovascular
1