Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K922896 |
Device Name |
VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL |
Applicant |
MED INSTITUTE, INC. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
NEAL E FEARNOT |
Correspondent |
MED INSTITUTE, INC. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
NEAL E FEARNOT |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 06/16/1992 |
Decision Date | 03/20/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|