Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K861250 |
Device Name |
MESULIN, INSULIN INFUSION SET |
Applicant |
MOLNLYCKE A/S HOSPITAL PRODUCTS |
HOEJVANGEN 6, |
DK-3060 ESPERGAERDE |
DENMARK,
DK
|
|
Applicant Contact |
BENTE LEWINSKY |
Correspondent |
MOLNLYCKE A/S HOSPITAL PRODUCTS |
HOEJVANGEN 6, |
DK-3060 ESPERGAERDE |
DENMARK,
DK
|
|
Correspondent Contact |
BENTE LEWINSKY |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/02/1986 |
Decision Date | 05/23/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|