Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K102590 |
Device Name |
FLEBOSET DOUBLE |
Applicant |
LABORATORIOS GRIFOLS, S.A. |
POL. LEVANTE C/CAN GUASCH, 2 |
PARETS DEL VALLES, BARCELONA,
ES
08150
|
|
Applicant Contact |
SEBASTIAN GASCON |
Correspondent |
LABORATORIOS GRIFOLS, S.A. |
POL. LEVANTE C/CAN GUASCH, 2 |
PARETS DEL VALLES, BARCELONA,
ES
08150
|
|
Correspondent Contact |
SEBASTIAN GASCON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/09/2010 |
Decision Date | 01/13/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|