Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K080660 |
Device Name |
IV ADMINISTRATION SET |
Applicant |
U.S. SAFETY SYRINGES CO., INC. |
1676 VILLAGE GREEN |
CROFTON,
MD
21114
|
|
Applicant Contact |
CHRISTINE SMITH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/10/2008 |
Decision Date | 05/13/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|