Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K070430 |
Device Name |
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS |
Applicant |
UNOMEDICAL A/S |
AAHOLMVEJ 1-3, OSTED |
ROSKILDE,
DK
DK-4000
|
|
Applicant Contact |
JOHN M LINDSKOG |
Correspondent |
UNOMEDICAL A/S |
AAHOLMVEJ 1-3, OSTED |
ROSKILDE,
DK
DK-4000
|
|
Correspondent Contact |
JOHN M LINDSKOG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/13/2007 |
Decision Date | 04/04/2007 |
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
|
|
|