Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K011071 |
FOIA Releasable 510(k) |
K011071
|
Device Name |
PARADIGM QUICK-SET INFUSION SET |
Applicant |
MAERSK MEDICAL A/S |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Applicant Contact |
GERDA RESCH |
Correspondent |
MAERSK MEDICAL A/S |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Correspondent Contact |
GERDA RESCH |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/09/2001 |
Decision Date | 06/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|