Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K970442 |
Device Name |
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM |
Applicant |
MED INSTITUTE, INC. |
1400 CUMBERLAND AVE. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
NEAL E FEARNOT |
Correspondent |
MED INSTITUTE, INC. |
1400 CUMBERLAND AVE. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
NEAL E FEARNOT |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 02/05/1997 |
Decision Date | 04/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|