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Manufacturers
US
Deltec, Inc.
Medical Device Manufacturer
·
US , St. Paul , MN
Deltec, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
3 cleared
·
Since 2002
5
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Deltec, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
May 23, 2003
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
K031361
·
FPA
General Hospital
·
23d
Cleared
Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655
·
LZG
General Hospital
·
165d
Cleared
Aug 13, 2002
GRIPPER PLUS NEEDLE
K021999
·
FPA
General Hospital
·
55d
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5
General Hospital
3
Gastroenterology & Urology
2