Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K061374 |
Device Name |
INTUITION INFUSION SETS |
Applicant |
UNOMEDICAL A/S |
AAHOLMVEJ 1-3, OSTED |
ROSKILDE,
DK
DK-4000
|
|
Applicant Contact |
RABI GHARABLI |
Correspondent |
UNOMEDICAL A/S |
AAHOLMVEJ 1-3, OSTED |
ROSKILDE,
DK
DK-4000
|
|
Correspondent Contact |
RABI GHARABLI |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/17/2006 |
Decision Date | 07/31/2006 |
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
|
|
|