Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K133867 |
Device Name |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) |
Applicant |
TERUMO EUROPE N.V. |
INTERLEUVENLAAN 40 |
LEUVEN,
BE
3001
|
|
Applicant Contact |
M.J. AERTS |
Correspondent |
TERUMO EUROPE N.V. |
INTERLEUVENLAAN 40 |
LEUVEN,
BE
3001
|
|
Correspondent Contact |
M.J. AERTS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/20/2013 |
Decision Date | 02/05/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|