Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K052887 |
Device Name |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS |
Applicant |
TERUMO EUROPE N.V. |
RESEARCHPARK ZONE 2 |
INTERLEUVENLAAN 40 |
LEUVEN 3001,
BE
3001
|
|
Applicant Contact |
M.J. AERTS |
Correspondent |
TERUMO EUROPE N.V. |
RESEARCHPARK ZONE 2 |
INTERLEUVENLAAN 40 |
LEUVEN 3001,
BE
3001
|
|
Correspondent Contact |
M.J. AERTS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/13/2005 |
Decision Date | 12/08/2005 |
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
|
|
|