Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K023917 |
Device Name |
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR |
Applicant |
KAWASUMI LABORATORIES, INC. |
1800 MASSACHUSETTS AVE. |
N.W. SUITE 200 |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
DONALD R STONE |
Correspondent |
KAWASUMI LABORATORIES, INC. |
1800 MASSACHUSETTS AVE. |
N.W. SUITE 200 |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
DONALD R STONE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/25/2002 |
Decision Date | 02/26/2003 |
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
|
|
|