Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K980994 |
Device Name |
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES |
Applicant |
VENETEC INTL., INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
ANITA PELLETIER |
Correspondent |
VENETEC INTL., INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
ANITA PELLETIER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/17/1998 |
Decision Date | 05/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|