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6706
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15404
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11476
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10380
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2875
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8115
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14563
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12831
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2711
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3210
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20
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6036
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5121
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3476
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3191
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17063
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899
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3300
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13266
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2718
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2525
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2129
Electrosurgical, Cutting &...
GEI
2002
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DZE
1372
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HRS
1301
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GCJ
1167
System, Imaging, Pulsed Doppler,...
IYN
1154
Polymer Patient Examination Glove
LZA
1146
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LNH
1021
Screw, Fixation, Bone
HWC
1016
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510k Database
Manufacturers
US
Holter-Hausner Intl.
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Medical Device Manufacturer
·
US , Mchenry , IL
Holter-Hausner Intl. - FDA 510(k) Cleared Devices
42 submissions
·
38 cleared
·
Since 1978
42
Total
38
Cleared
0
Denied
28
devices
26-28 of 28
Filters
1
2
Cleared
Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
K790126
·
JXG
Neurology
·
2d
Cleared
Jan 15, 1979
CATHETERS, H-H VENTRICULAR
K782105
·
JXG
Neurology
·
27d
Cleared
Nov 14, 1978
CATHETERS, H-H ATRIAL AND PERITONEAL
K781768
·
JXG
Neurology
·
29d
1
2
Filters
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All
42
Neurology
28
Orthopedic
8
Gastroenterology & Urology
3
General Hospital
1
General & Plastic Surgery
1
Anesthesiology
1