Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K963981 |
Device Name |
VYGON BIONECTOR WITH EXTENSION SET |
Applicant |
VYGON CORP. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
ANNE MARIE CESARIO |
Correspondent |
VYGON CORP. |
1129 BLOOMFIELD AVE. |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
ANNE MARIE CESARIO |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/03/1996 |
Decision Date | 02/14/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|