Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K791496 |
Device Name |
LOW PLASTICIZER ADMINISTRATION SETS |
Applicant |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/03/1979 |
Decision Date | 04/08/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|