Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K993848 |
Device Name |
MILLENNIUM HUBER PLUS SAFETY INFUSION SET |
Applicant |
MILLENNIUM MEDICAL DISTRIBUTION, INC. |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Applicant Contact |
CHRISTINE EMANUEL |
Correspondent |
MILLENNIUM MEDICAL DISTRIBUTION, INC. |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Correspondent Contact |
CHRISTINE EMANUEL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/12/1999 |
Decision Date | 01/27/2000 |
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
|
Recalls |
CDRH Recalls
|
|
|