Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K010103 |
Device Name |
SURSHIELD WINGED INFUSION SET |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
BARBARA SMITH |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
BARBARA SMITH |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/12/2001 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|