Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K001368 |
Device Name |
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER |
Applicant |
CARMEL PHARMA AB. |
BOX 5352 |
GOTHENBURG,
SE
40228
|
|
Applicant Contact |
KJELL ANDREASSON |
Correspondent |
CARMEL PHARMA AB. |
BOX 5352 |
GOTHENBURG,
SE
40228
|
|
Correspondent Contact |
KJELL ANDREASSON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/01/2000 |
Decision Date | 05/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|