Device Classification Name |
Pump, Infusion
|
510(k) Number |
K851360 |
Device Name |
IMED GRAVISET INTRAVASCULAR ADMIN. SET |
Applicant |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Applicant Contact |
RALPH H JARBOE |
Correspondent |
IMED CORP. |
9775 BUSINESSPARK AVE. |
SAN DIEGO,
CA
92131 -1699
|
|
Correspondent Contact |
RALPH H JARBOE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 04/04/1985 |
Decision Date | 05/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|