Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K000592 |
Device Name |
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET |
Applicant |
MYCO MEDICAL SUPPLIES, INC. |
101 ROSE VALLEY WOODS DR. |
CARY,
NC
27513
|
|
Applicant Contact |
SANJIV KUMAR |
Correspondent |
MYCO MEDICAL SUPPLIES, INC. |
101 ROSE VALLEY WOODS DR. |
CARY,
NC
27513
|
|
Correspondent Contact |
SANJIV KUMAR |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/22/2000 |
Decision Date | 04/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|