510k
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333
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1070
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271
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816
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148
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630
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1323
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763
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100
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72
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1
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366
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584
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244
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155
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2055
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40
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310
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1586
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132
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229
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211
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System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
206
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System, Image Processing,...
199
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
169
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Abutment, Implant, Dental,...
160
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Intervertebral Fusion Device...
138
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Thoracolumbosacral Pedicle Screw...
135
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Polymer Technology Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Polymer Technology Corp. - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 1983
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Polymer Technology Corp.
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 28, 1992
GLUCOSE TEST SYSTEM
K923587
·
CGA
Chemistry
·
188d
Cleared
Mar 04, 1992
FIRST CHOICE
K912580
·
CGA
Chemistry
·
266d
Cleared
Sep 10, 1991
FIRST CHOICE(TM)
K912732
·
CGA
Chemistry
·
82d
Cleared
May 15, 1991
FIRST CHOICE(TM), MODIFICATION
K911792
·
CGA
Chemistry
·
23d
Cleared
Oct 06, 1989
FIRST CHOICE (TM)
K893205
·
CGA
Chemistry
·
163d
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23
Ophthalmic
10
Chemistry
5
Pathology
4
General Hospital
2
General & Plastic Surgery
1
Microbiology
1