Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K860541 |
Device Name |
SOLUTION ADMINISTRATION SET |
Applicant |
TRAVENOL LABORATORIES, S.A. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
BRIAN STEMBAL |
Correspondent |
TRAVENOL LABORATORIES, S.A. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
BRIAN STEMBAL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/12/1986 |
Decision Date | 03/25/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|