Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K100720 |
Device Name |
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING |
Applicant |
KAWASUMI LABORATORIES, INC. |
1601 K STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
SUZAN ONEL |
Correspondent |
KAWASUMI LABORATORIES, INC. |
1601 K STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
SUZAN ONEL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/15/2010 |
Decision Date | 11/18/2010 |
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
|
|
|