Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K832284 |
Device Name |
SOLUTION ADMIN. SET 2C9096 W/10 PVC |
Applicant |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/13/1983 |
Decision Date | 12/29/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|