Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K051264 |
Device Name |
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS |
Applicant |
UNOMEDICAL A/S |
AAHOLMVEJ 2, OSTED |
ROSKILDE,
DK
4000
|
|
Applicant Contact |
JOHN LINDSKOG |
Correspondent |
UNOMEDICAL A/S |
AAHOLMVEJ 2, OSTED |
ROSKILDE,
DK
4000
|
|
Correspondent Contact |
JOHN LINDSKOG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/16/2005 |
Decision Date | 09/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|