Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K123344 |
Device Name |
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) |
Applicant |
KAWASUMI LABORATORIES, INC. |
7401 104TH AVE. STE 160 |
KENOSHA,
WI
53142
|
|
Applicant Contact |
CHRISTINA HENZA |
Correspondent |
KAWASUMI LABORATORIES, INC. |
7401 104TH AVE. STE 160 |
KENOSHA,
WI
53142
|
|
Correspondent Contact |
CHRISTINA HENZA |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/31/2012 |
Decision Date | 03/07/2013 |
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
|
|
|