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Manufacturers
AU
Bionica, Inc.
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Medical Device Manufacturer
·
AU , Nsw 2120 Australia
Bionica, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1987
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionica, Inc.
General Hospital
✕
3
devices
1-3 of 3
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Cleared
Dec 27, 1989
AMBULATORY INFUSION PUMP
K895426
·
FRN
General Hospital
·
113d
Cleared
May 11, 1988
BIONICA MDS 110 PCA
K875316
·
FRN
General Hospital
·
134d
Cleared
Mar 17, 1987
PERSONAL INFUSION PUMP
K864276
·
FRN
General Hospital
·
139d
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General Hospital
3