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449
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386
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359
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346
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303
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285
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Orthopedic Stereotaxic Instrument
285
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Manufacturers
US
Bioteque Corp.
Medical Device Manufacturer
·
US , Levittown , PA
Bioteque Corp. - FDA 510(k) Cleared Devices
11 submissions
·
10 cleared
·
Since 1992
11
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioteque Corp.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 22, 2004
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
K032292
·
FOZ
General Hospital
·
242d
Cleared
Sep 14, 2001
BIOTEQUE SCALP VEIN SET
K012526
·
FPA
General Hospital
·
39d
Cleared
Dec 22, 2000
BIOTEQ I.V. (INTRAVENOUS) SET
K002449
·
FPA
General Hospital
·
135d
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11
Gastroenterology & Urology
5
General Hospital
3
Cardiovascular
2
Obstetrics & Gynecology
1